REQUIREMENTS FOR THE MANUFACTURE, IMPORT AND SALE OF

MEDICAL DEVICES

Note: The manufacture, import and sale of Medical Devices, which have been

notified as drugs are regulated under the Drugs & Cosmetics Act and Rules.

All application of devices for manufacture of devices shall be made in accordance

of Rule 76, but in case of inspections and other requirements Schedule M III will

apply.

1.1 For the purposes of this Schedule any instrument, apparatus,

implement, machine, appliance, implant, in vitro reagent or calibrator, software,

material or other similar or related article shall be deemed to be a Device under

the meaning of Section 3 (b) (iv), which is:

(a) intended by the manufacturer to be used alone or in combination for

human beings for one or more specific purpose(s) of;

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for

an injury,

(iii) investigation, replacement, modification or support of the anatomy or

of a physiological process,

(iv) supporting or sustaining life,

(v) control of conception,

(vi) disinfection of medical devices,

(vii) providing information for medical or diagnostic purposes by means

of in vitro examination of specimens derived from the human body;

and

(b) which does not achieve its primary intended action in or on the human

body by pharmacological, immunological or metabolic means, but which

may be assisted in its intended function by such means.

example, reagents, calibrators, sample collection and storage devices, control

materials and related instruments or apparatus. The information provided by such

covered by separate regulations under D&C Act.

Note 2: Accessories intended specifically by manufacturers to be used

together with a ‘parent’ medical device to enable that medical device to achieve

its intended purpose are subject to the same procedures as apply to the medical

device itself. For example, an accessory will be classified as though it is a

medical device in its own right. This may result in the accessory having a different

classification than the ‘parent’ device.

Note 3: Components to medical devices are generally controlled through the

manufacturer’s quality management system and the conformity assessment

procedures for the device.

Note 3a: Semi-finished products, in specific processes performed by sub

contractors are to be generally controlled through the manufacturer’s quality

management system and the conformity assessment procedures for the device.

Note 4: (1) ‘accessory’ means an article which whilst not being a device is

intended specifically by its manufacturer to be used together with a device to

enable it to be used in accordance with the use of the device intended by the

manufacturer of the device;

reagent, reagent product, calibrator, control material, kit, instrument, apparatus,

equipment or system, whether used alone or in combination, intended by the

blood and tissue donation from the human body, solely or principally for the

purpose of providing information:

(a) concerning a physiological or pathological state, or

(b) concerning a congenital abnormality, or

(c) to determine the safety and compatibility with potential recipients, or

(d) to monitor therapeutic measures.

devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not,

specifically intended by their manufacturers for the primary containment and

diagnostic medical devices

(3) ‘custom-made device’ means any device specifically made in

accordance with a duly qualified medical practitioner's written prescription which

gives, under his responsibility, specific design characteristics and is intended for

the sole use of a particular patient.

Mass-produced devices which need to be adapted to meet the specific

requirements of the medical practitioner or any other professional user shall not

be considered to be custom-made devices;

(4) ‘device intended for clinical investigation’ means any device intended for

use by a duly qualified medical practitioner or by paramedical personnel when

conducting investigations as referred to in Section 2.1 of Annex X in an adequate

human clinical environment. For the purpose of conducting clinical investigation,

any other person who, by virtue of his professional qualifications, is authorized to

carry out such investigation shall be accepted as equivalent to a duly qualified

medical practitioner;

(5) ‘intended purpose’ means the use for which the device is intended

according to the data supplied by the manufacturer on the labelling, in the

instructions and/or in promotional materials;

(6) ‘clinical data’ means the safety and/or performance information that is

generated from the use of a device. Clinical data are sourced from:

(a) clinical investigation(s) of the device concerned; or

(b) clinical investigation(s) or other studies reported in the scientific literature,

of a similar device for which equivalence to the device in question can be

demonstrated; or

(c) published and/or unpublished reports on other clinical experience of either

the device in question or a similar device for which equivalence to the

device in question can be demonstrated;

(7) ‘device subcategory’ means a set of devices having common areas of

intended use or common technology;

(8) ‘generic device group’ means a set of devices having the same or similar

intended uses or commonality of technology allowing them to be classified in a

generic manner not reflecting specific characteristics;

(9) ‘single use device’ means a device intended to be used once only for a

single patient.

(10) ‘placing on the market’ means the first making available in return for

payment or free of charge of a device other than a device intended for clinical

investigation, with a view to distribution and/or use in the market, regardless of

whether it is new or fully/partly refurbished;

(11) ‘putting into service’ means the stage at which a device is ready for use

in the market for the first time for its intended purpose.

(12) Notified Body is a formally designated conformity assessment body

which verifies the product and reviews the technical documentation and assesses

whether the product and technical documentation in respect of a product

demonstrates that the relevant essential requirements have been met. The

Notified Body may also audit the manufacturer’s quality management system

according to regulatory requirements. As appropriate, the Notified Body issues

certificates of conformity.

(13) ‘Authorized Representative’ means any natural or legal person established

within India who has received a mandate from the manufacturer to act on his

behalf for specified tasks with regard to the latter’s obligations under that country

or jurisdiction’s legislation.

(14) 'manufacturer' means the natural or legal person with responsibility for the

design, manufacture, packaging and labelling of a device before it is placed on

the market under his own name,( regardless of whether these operations are

carried out by that person himself or on his behalf by a third party). The

obligations of this Directive to be met by manufacturers also apply to the natural

or legal person who assembles, packages, processes, fully refurbishes and/or

labels one or more ready-made products and/or assigns to them their intended

purpose as a device with a view to their being placed on the market under his

own name. This subparagraph does not apply to the person who, while not a

manufacturer within the meaning of the first subparagraph, assembles or adapts

devices already on the market to their intended purpose for an individual patient;

source of electrical energy or any source of power other than that directly generated

by the human body or gravity and which acts by converting this energy. Medical

devices intended to transmit energy, substances or other elements between an

active medical device and the patients, without any significant change, are not

considered to be active medical devices.

or in combination with other medical devices, to support, modify, replace or restore

biological functions or structures with a view to treatment or alleviation of an illness,

injury or handicap.

used alone or in combination with other medical devices, to supply information for

detecting, diagnosing, monitoring or to support in treating physiological conditions,

states of health, illnesses or congenital deformities.

1.2 a) Where a device is intended to administer a medicinal product within

the meaning of D&C Act relating to medicinal products for human use it shall be

governed by this schedule. If, however, such a device is placed on the market in

such a way that the device and the medicinal product form a single integral

product which is intended exclusively for use in the given combination and which

is not reusable, that single product shall not be governed by this Schedule. The

relevant essential requirements of Annex I shall apply to that product as far as

safety and performance related device features are concerned. (Eg : Prefilled

Insulin Syringe )

b) Where a device incorporates, as an integral part, a substance which, if

used separately, may be considered to be a medicinal product within the

meaning of the D&C Act and which is liable to act upon the body with action

ancillary to that of the device, that device shall be assessed and authorized in

accordance with this schedule.

(Eg : Drug Eluting Stent. )

c) Where a device incorporates, as an integral part, a substance which, if

used separately, may be considered to be a medicinal product constituent or a

medicinal product derived from human blood or human plasma within the

meaning of the D&C Act and which is liable to act upon the human body with

action ancillary to that of the device, hereinafter referred to as a ‘human blood

derivative’, that device shall be assessed and authorized in accordance with this

schedule. (Eg : .Cord blood coated stent )

d) This Schedule shall not apply to:

(i) medicinal products covered by D&C Act. In deciding whether a product

falls under the drug category under D&C Act or Medical Devices under this

Schedule, particular account shall be taken of the principal mode of action of the

product;

(ii) cosmetic products covered by D&C Act

(iii) human blood, blood products, plasma or blood cells of human origin or

to devices which incorporate at the time of placing on the market such blood

products, plasma or cells, ;

(iv) transplants or tissues or cells of human origin or to products

incorporating or derived from tissues or cells of human origin,;

(v) transplants or tissues or cells of animal origin, unless a device is

manufactured utilizing animal tissue which is rendered non-viable or non-viable

products derived from animal tissue on the approximation of provisions laid down

by law, regulation or administrative action relating to proprietary medicinal

products and laying down special provisions for medicinal products derived from

human blood or human plasma.

Medical Devices shall be classified as per their risk level and intended use . They

shall be divided into Classes A,B,C,D. Classification shall be carried out in

accordance with Annex IX.

The classification rules set out in Annex IX may be adapted by CLAA in

accordance in the light of technical progress and any information which becomes

incidents occurring following placing of devices on the market)

Whereas the classification rules are based on the vulnerability of the human

body taking account of the potential risks associated with the technical design

and manufacture of the devices;

2.1 Risk Level

The examples given are for illustration only and the classification of Medical

Devices must be done as per the classification rules for each medical device

according to its intended purpose.

Low-moderate

Risk

Hypodermic Needles / suction equipment

Moderate-high

Risk

Lung ventilator / bone fixation plate

High Risk

Heart valves / implantable defibrillator

requirements as the device risk class increases. These regulatory controls

may include, for example: -

claims;

manufacturer’s quality system; and

Device Class: A B C D

Regulatory

requirements

HIGHER

LOWER

The classification rules generally enable medical devices to be appropriately

classified.

In view of the diverse nature of the devices and technological progress in

this field, steps must be taken to include amongst the implementing powers

conferred on the CLAA the decisions to be taken with regard to the proper

classification or reclassification or confirmation of the classification of the devices

or, where appropriate, the adjustment of the classification rules themselves;

The confirmation of compliance with the essential requirements may mean

that clinical investigations have to be carried out by the manufacturer; as per

requirements of clinical investigation of this schedule.

For the purpose of carrying out the clinical investigations, appropriate

means have to be specified for the protection of public health and public order;

If a manufacturer desires to reclassify a device to a lower class, it must

submit justification to the CLAA for evaluation that less stringent class

requirement will assure sufficient safety and effectiveness of the device.

Whereas medical devices should provide patients, users and third parties

with a high level of protection and attain the performance levels attributed to them

by the manufacturer; whereas, therefore, the maintenance or improvement of the

level of protection attained in the country is one of the essential objectives of this

Schedule;

Whereas, for the purpose of this Schedule Compliance with the essential

requirements shall be presumed in respect of devices when the manufacturer

relies on relevant latest BIS standard(s) or ISO standard(s) or any other official

standard(s) or the manufacturer’s own validated standard(s).

Harmonized conformity assessment procedures shall be the responsibility of

manufacturers and notified bodies for carrying out conformity assessment on the

basis of the type of devices intended to be manufactured.

Whereas the details added to these procedures are justified by the nature of

the verification required for medical devices;

Whereas it is necessary, essentially for the purpose of the conformity

assessment procedures, to group the devices into four product classes;

The conformity assessment procedures for Class A devices can be carried out,

as a general rule, under the sole responsibility of the manufacturers in view of the

low level of vulnerability associated with these products; The manufacturers are

not required to obtain manufacturing license from Central Licensing Authority

CLAA. Class A device manufacturer shall register with the CLAA.

For Class B devices, a notified body should assess and certify the

manufacturing facility quality management system. Based on the assessment by

Notified body CLAA shall have no objection to manufacture such device(s). Class

B device manufacturers shall register with the CLAA.

For device(s) falling under Class C which constitute a medium high risk

potential, certification by a notified body is required with regard to the design and

manufacture of the device(s). The manufacturers are required to apply for a

license along with supportive documents with respect to safety and effectiveness

of these devises to CLAA. Based on these documents and certificate issued by

the Notified body, the manufacturing license will be issued by CLAA.

For devices falling under Class D which constitute a high risk potential,

certification by a notified body is required with regard to the design and

manufacture of the devices. The manufacturers are required to apply for a license

along with the supportive documents in respect of safety and effectiveness of

these devices to CLAA. The class D devices manufacturing facility will also be

inspected jointly by CLAA and state licensing authority. Based on the

recommendations of joint inspections report and the certification by the Notified

body, the manufacturing license will be issued by CLAA.

The manufacturer which has already gone through Quality Management

system (QMS) and product certification through a Notified body elsewhere need

to produce approval documents for consideration of registration or licensing of

Any expenses incurred by an applicant for assessment and certification by

the notified body shall be borne by the manufacturer only.

Fees required to be paid for obtaining a license in this schedule shall be as

specified in relevant D&C Act Rules.

Medical devices sold in this country should, as a general rule, bear the

conformity with the provisions of this schedule to enable them to move freely

within the Country and to be put into service in accordance with their intended

purpose;

Wherever possible sampling of a medical devices shall be carried out in

accordance of the procedure laid down in Drugs and Cosmetics Act, 1940. In

case the nature of the devices is such that above procedure cannot be adopted,

CLAA may take samples for evaluation from experts in the field or take any other

The devices must meet the essential requirements set out in Annex I which

apply to them, taking account of the intended purpose of the devices concerned.

Once a medical device is placed on the market in India, the manufacturer

shall adhere to requirements of post-marketing surveillance (PMS) to

systematically monitor the performance of the device during use. As appropriate,

events meeting certain criteria should be analyzed and reported to a designated

authority (“vigilance reports”). As part of the manufacturer’s Quality Management

System, appropriate corrective and preventive actions may be applied to prevent

the recurrence of adverse events. Medical device manufacturers should comply

with post-marketing surveillance and vigilance reporting guidance provided

hereinafter. In addition, the manufacturer should submit to CLAA vigilance

reports for analysis. The Manufacturer shall follow the procedure referred to in

Annex XII in respect of Adverse Event Reporting.

6.1 CLAA shall not create any obstacle to the placing on the market or the putting

into service within the country devices bearing the ICAC marking provided for in

ICAC marking which indicate that they have been the subject of an assessment

of their conformity in accordance with the provisions of Conformity Assessment

procedure (11)

Note : It should be understood the requirement to bear the ICAC mark also

applies to devices in Classes A and B (which do not require conformity

assessment by a Notified Body.

6.2 CLAA shall not create any obstacle to:

Devices intended for clinical investigation being made available to medical

practitioners or authorized persons for that purpose if they meet the conditions laid

down in Clinical Investigation (14) and in Declaration of Conformity (Annex VII )

and bear form12 License under D&C Act.

Custom-made devices being placed on the market and put into service if

they meet the conditions laid down; Class B, C and D devices shall be

accompanied by the statement, which shall be available to the particular patient

or user identified by name, an acronym or a numerical code.

These devices may not bear the ICAC marking.

6.2 At trade fairs, exhibitions, demonstrations, etc. there shall not be any

obstacle to the showing of devices which do not conform to this Schedule,

provided that a visible sign clearly indicates that such devices cannot be

marketed or put into service until they have been made to comply and the

manufacturer has permission under appropriate Rules of the D&C Act.

1. In order for the manufacturer to demonstrate conformity with the relevant

regulatory requirements, the CLAA shall adopt and recognize BIS 15575 or its

revisions and ISO 13485 in respect of the specifications to be followed for Quality

Management Systems.

2. For the purposes of this Schedule, reference to harmonized standards

combination of pharmaceutical and devices.

The packaging of medical devices shall be labelled as per the Annex XIII

and relevant ISO standards .

Additionally relevant internationally accepted symbols denoting sterilization,

single use etc, as per ISO 15223-1:2007shall also be depicted.

Note 1: Medical Devices shall be exempted from mentioning Date of

manufacture in labelling.

Note 2: In case of medical devices sold in bulk packaging without any

primary packaging, labelling shall be on the bulk package.

Note 3: In case of Medical Devices imported to the country, the importer can

take permission for further labelling of the package under provision of Rule 104A

of the drugs and cosmetic rules from the CLAA before release for sale in the

market.

Note 4: The rules for labelling specified as per Rule 109A shall not be

applicable to medical devices

7.3 Shelf Life: In special circumstances to be mentioned in writing and

permission taken thereof from the CLAA, shelf life of imported medical devices

may not be covered under Rule 31 of the D&C Rules.

An Expert Committee consisting of experts of relevant fields of the devices

constituted by the Government shall assist CLAA in evaluation of application of

devices.

Where CLAA ascertains that the devices, when correctly installed,

maintained and used for their intended purpose, may compromise the health

and/or safety of patients, users or, where applicable, other persons, it shall take

all appropriate interim measures to withdraw such devices from the market or

prohibit or restrict their being placed on the market or put into service.

The CLAA shall immediately inform the manufacturer or importer of any

such measures, indicating the reasons for its decision and, in particular, whether

non-compliance is due to:

(a) failure to meet the essential requirements referred to in. 6 (Free movement,

devices

intended for special purposes )

(b) incorrect application of the standards referred to in 7.(Reference to

standards)

(c) Shortcomings in standard themselves

10.1. CLAA shall take the necessary steps to ensure that any information

brought to their knowledge, in accordance with the provisions of this Schedule,

regarding the incidents mentioned below involving a Class A, B, C or D device is

recorded and evaluated centrally:

(a) any malfunction or deterioration in the characteristics and/or

performance of a device, as well as any inadequacy in the labelling or the

instructions for use which might lead to or might have led to the death of a patient

or user or to a serious deterioration in his state of health;

(b) any technical or medical reason in relation to the characteristics or

performance of a device for the reasons referred to in subparagraph (a), leading

to systematic recall of devices of the same type by the manufacturer.

10.2. Where the CLAA requires medical practitioners or the medical

institutions to inform the competent authorities of any incidents referred to in

paragraph 1, it shall take the necessary steps to ensure that the manufacturer of

the device concerned, or his authorized representative is also informed of the

incident.

10.3. After carrying out an assessment if possible together with, the

manufacturer or his authorized representative, without prejudice to Safe Guard (9)

Clause shall immediately inform the CLAA of measures that have been taken or

are contemplated to minimise the recurrence of the incidents referred to in

paragraph 10.1, including information on the underlying incidents.

10.4. Any appropriate measures to adopt procedures to implement this

action shall be taken in accordance to the Dugs & Cosmetic Rules.

11.1. In the case of devices falling within Class B, other than devices which

are custom-made or intended for clinical investigations, the manufacturer shall, in

order to affix the ICAC marking, follow the procedure relating to the ICAC

declaration of conformity set out in Annex VII and coupled with either:

(a) the procedure relating to the ICAC verification set out in Annex IV

or

(b) the procedure relating to the ICAC declaration of conformity production

quality assurance set out in Annex V

or

(c) the procedure relating to the ICAC declaration of conformity in product

quality assurance set out in Annex VI.

(d) Instead of applying this procedure the manufacturer may also follow the

procedure referred to in the paragraph 11.2 (a).

11.2. In the case of devices falling within Class C, other than devices which

are custom-made or intended for clinical investigations, the manufacturer shall, in

order to affix the ICAC marking, either:

(a) follow the procedure relating to the ICAC declaration of conformity full

quality assurance set out in Annex II; in this case point 4 of Annexure II

is not applicable.

Or

(b) follow the procedure relating to the ICAC type-examination set out in

Annex III coupled with:

(i) the procedure relating to the ICAC verification set out in Annex IV or

quality assurance set out in Annex V; or

quality assurance set out in Annex VI.

11.3. In the case of devices falling within Class D, other than devices which

are custom-made or intended for clinical investigations, the manufacturer shall, in

order to affix the ICAC marking, either:

(a) follow the procedure relating to the ICAC declaration of conformity full

quality assurance set out in Annex II; or

(b) follow the procedure relating to the ICAC type-examination set out in

Annex III coupled with:

(i) the procedure relating to the ICAC verification set out in Annex IV or

(ii) the procedure relating to the ICAC declaration of conformity production

quality assurance set out in Annex V.

11.4. In the case of devices falling within Class A, other than devices which

are custom-made or intended for clinical investigations, the manufacturer shall, in

order to affix the ICAC marking, follow the procedure referred to in Annex VII and

draw up the ICAC declaration of conformity required before placing the device on

the market.

11.5. In the case of custom-made devices, the manufacturer shall follow the

procedure referred to in Annex VIII and draw up the statement set out in that

Annex before placing each device on the market.

CLAA may require that the manufacturer shall submit a list of such devices which

have been put into service in the country .

11.6. During the conformity assessment procedure for a device, the

manufacturer and/or the notified body shall take account of the results of any

assessment and verification operations which, where appropriate, have been

carried out in accordance with this Schedule at an intermediate stage of

manufacture.

11.7. Where the conformity assessment procedure involves the intervention

of a notified body, the manufacturer, or his authorized representative may apply

to a body of his choice within the framework of the tasks for which the body has

been notified.

11.8. The notified body may require, where duly justified, any information or

data, which is necessary for establishing and maintaining the attestation of

conformity in view of the chosen procedure.

11.9 Certificate issued by the notified bodies in accordance with this

Schedule shall be valid for a maximum of five years.

By derogation from above mentioned cases,(11.1 to 11.5) the CLAA may

authorize, on duly justified request, the placing on the market and putting into

service, within the country, of individual devices for which the procedures referred

to in above paragraphs ,(11.1 to 11.5) have not been carried out and the use of

which is in the interest of protection of health.

11.10 Any manufacturer or authorized agent who wants to market in the India a

Class B, C, and D device intended for human use, which if proved to be

substantially equivalent at least as safe and effective to a legally marketed

device or if device is already approved by CE/USFDA or any other major

regulatory body may be considered for a manufacturing license based on

supportive documents submitted to CLAA. Submitters must compare their device

to one or more similar legally marketed devices and make and support their

substantial equivalency claims. The legally marketed device(s) to which

equivalence is drawn is commonly known as the "predicate."

Before marketing a device, each submitter must receive an order, in the form of a

Registration Certificate, from CLAA which finds the device to be substantially

equivalent (SE) and states that the device can be marketed in India. This order

"clears" the device for commercial distribution.

11.11: Periodic Safety Update data compilation and submission (PSUR) / Clinical

11.12The periodicity of surveillance audit will be annual .

By way of derogation from 11 the following paragraphs shall apply to systems

and procedure packs.

12.1 Any manufacturer who puts devices bearing the ICAC marking together

within their intended purpose and within the limits of use specified by their

manufacturers, in order to place them on the market as a system or procedure

pack, shall draw up a declaration by which he states that:

(a) he has verified the, mutual compatibility of the devices in accordance

with the manufacturers' instructions and has carried out his operations in

accordance with these instructions; and

(b) he has packaged the system or procedure pack and supplied relevant

information to users incorporating relevant instructions from the

manufacturers; and

(c) the whole activity is subjected to appropriate methods of internal control

and inspection.

Where the conditions above are not met, as in cases where the system or

procedure pack incorporate devices which do not bear a ICAC mark or

Where the chosen combination of devices is not compatible in view of their

original intended use, the system or procedure pack shall be treated as a device

in its own right and as such subjected to the relevant procedure pursuant to 11.

12.2 Any Licensed firm /entity who sterilizes, for the purpose of placing on

the market, systems or procedure packs referred to in 12.1 or other ICACmarked

medical devices designed by their manufacturers to be sterilized before

use, shall, at his choice, follow one of the procedures referred to in the quality

systems as per Annex IV,V or VI and relevant BIS and ISO standards. The

application of the abovementioned and the intervention of the notified body are

limited to the aspects of the procedure relating to the obtaining of sterility until the

sterile package is opened or damaged. The person shall draw up a declaration

stating that sterilisation has been carried out in accordance with the

manufacturer's instructions.

The products referred to in paragraphs 12.1 and 12.2 themselves shall not bear

an additional ICAC marking. They shall be accompanied by the information

referred to point 13 of Annex I which includes where appropriate, the information

supplied by the manufacturer of the devices which have been put together.. If the

labelled intended use(s) of the system or procedure pack differs from that of the

original device(s), then it should require a new conformity assessment procedure

and a new ICAC mark.

12.3 The declarations referred to in paragraphs 12.1 and 12.2 shall be kept

at the disposal of the CLAA. for a period of 5 years.

Where CLAA considers in relation to a given product or group of products, that, in

order to ensure protection of health and safety and/or to ensure that public health

requirements are observed, such products should be withdrawn from the market,

or their placing on the market and putting into service should be prohibited,

restricted or subjected to particular requirements, it may take any necessary and

justified transitional measures. CLAA shall then inform the Notified Body,

manufacturer and all other Stakeholders, giving the reasons for its decision. The

CLAA shall, whenever possible, consult the interested Parties.

The CLAA shall adopt its opinion, indicating whether the national measures are

justified or not. The CLAA shall inform all the stakeholders and the consulted

interested Parties thereof. When appropriate, the necessary measures designed

to amend non- essential elements of this Schedule MIII, relating to withdrawal

from the market, prohibition of placing on the market and putting into service of a

certain product or group of products or to restrictions or intro- duction of

particular requirements in order for such products to be put on the market,

shall be adopted in accordance with the regulatory procedure with scrutiny

referred to in D&C Act. On imperative grounds of urgency, the CLAA may

exceptionally use the urgency procedure referred to in D&C Act.

14.1. In the case of devices intended for clinical investigations, the

manufacturer or the authorized representative of the manufacturer shall follow the

procedure referred to in Annex VIII and notify the CLAA

14.2. In the case of devices falling within Class D and implantable and longterm

invasive devices falling within Class B or C, the manufacturer may

commence the relevant clinical investigation after obtaining approval from CLAA.

14.3. In the case of devices other than those referred to in paragraph 14.2,

CLAA may authorize manufacturers to commence clinical investigations

immediately after the date of information and submission to CLAA, provided that

the ethics committee concerned has issued a favourable opinion on the program

of investigation in question including its review of the clinical investigation plan.

14.4. Clinical investigation shall be conducted in accordance with provisions

of Annex X and in the manner provided in ISO 14155.

14.4. The manufacturer or his authorized representative shall notify the

CLAA of the end of the clinical investigation, with a justification in case of early

termination.

14.5. The provisions of paragraphs 14.1 and 14.2 do not apply where the

clinical investigations are conducted using devices which are authorized in

accordance with conformity assessment to bear the ICAC mark unless the aim of

these investigations is to use the devices for a purpose other than that referred to

in the relevant conformity assessment procedure. The relevant procedure of

Annex X remains applicable.

Notified bodies for conformity assessment and /or ICAC certification of the

medical devices shall be listed by the CLAA in consultation with the BIS or any

other such competent body and publicly circulated for the benefit of the users of

such services.

1. Manufacturer shall notify the CLAA of the Accredited Notified Bodies

which they have selected for carrying out the tasks pertaining to the procedures

referred to in conformity assessment and the specific tasks for which the Notified

Bodies have been designated.

2. The appointed Notified bodies by the Manufacturer shall be compliant

with the criteria set out in this Schedule (Annex XI).

3. After manufacturer has notified a notified body to CLAA,it shall withdraw

that notification if it finds that the body no longer meets the criteria set out.

4. The notified body and the manufacturer, or his authorized representative,

shall lay down, by common accord, the time limits for completion of the

assessment and verification operations referred to in Annexes relating to

Declaration of Conformity to Quality Assurance Systems for Production,

Declaration of Conformity to Quality Assurance Systems for Product, Type

Examination and Verification.

5. The notified body shall inform the CLAA about all certificates issued,

modified, supplemented, suspended, withdrawn or refused and the other notified

bodies within the scope of this Schedule M III about certificates suspended,

withdrawn or refused and, on request, about certificates issued. The notified body

shall also make available, on request, all additional relevant information.

6. Where a notified body finds that pertinent requirements of this Schedule

M III have not been met or are no longer met by the manufacturer or where a

certificate should not have been issued, it shall, taking account of the principle of

proportionality, suspend or withdraw the certificate issued or place any

restrictions on it unless compliance with such requirements is ensured by the

implementation of appropriate corrective measures by the manufacturer. In the

case of suspension or withdrawal of the certificate or of any restriction placed on

it or in cases where an intervention of the CLAA may become necessary, the

notified body shall inform CLAA thereof.

7. The notified body shall, on request, supply all relevant information and

documents, required to enable the CLAA to verify compliance with Annex XI

requirements of Schedule M III.

8. CLAA will have the its right to review the functioning of the Notified body

either pro actively or with respect to complaint redressal.

9. In the event of a dispute between the manufacturer and the notified body

concerned, resulting from the application of the classification rules, the matter

shall be referred for decision to the CLAA.

10. Change of Notified body can be after obtaining No objection certificate

from existing one.

1. Devices, other than devices which are custom-made or intended for

clinical investigations, considered to meet the essential requirements referred to

in Rule 3 must bear the ICAC marking of conformity when they are placed on the

market.

2. The ICAC marking of conformity, consisting of the initials ‘IC’ must

appear in a visible, legible and indelible form on its packaging, where practicable

and appropriate, and on the instructions for use. Where applicable, the ICAC

marking must also appear on the sales packaging.

The various components of the ‘IC’ marking must be vertical, and may not

be less than 5mm in height.

It shall be accompanied by the identification number of the notified body

issued by CLAA responsible for implementation of the procedures set out in

Annexes II, IV, V and VI.

3. It is prohibited to affix marks or inscriptions which are likely to mislead

third parties with regard to the meaning or the graphics of the ICAC marking. Any

other mark may be affixed to the device, to the packaging or to the instruction

leaflet accompanying the device provided that the visibility and legibility of the

ICAC marking is not thereby reduced.

(a) where CLAA establishes that the ICAC marking has been affixed unduly

or is missing in violation of the Schedule M III, the manufacturer or his authorized

representative shall be obliged to end the infringement under conditions imposed

by the CLAA;

(b) where non-compliance continues, the CLAA must take all appropriate

measures to restrict or prohibit the placing on the market of the product in

question or to ensure that it is withdrawn from the market, in accordance with the

procedure in this Schedule. (No 9).

Those provisions shall also apply where the ICAC marking has been affixed

in accordance with the procedures in this Schedule M III, but inappropriately, on

products that are not covered by this Schedule M III.

1. Any decision taken pursuant to this Schedule M III:

(a) to refuse or restrict the placing on the market or the putting into service

of a device or the carrying out of clinical investigations;

or

(b) to withdraw devices from the market, shall state the exact grounds on

which it is based. Such decisions shall be notified without delay to the party

concerned, who shall at the same time be informed of the remedies available to

him under the Drugs & Cosmetics Act in question and of the time limits to which

such remedies are subject.

2. In the event of a decision as referred to in paragraph 1, the manufacturer,

or his authorized representative shall have an opportunity to put forward his

viewpoint in advance, unless such consultation is not possible because of the

urgency of the measure to be taken

his authorized representative shall have an opportunity to put forward his

viewpoint in advance advance, unless such consultation is not possible because

of the urgency of the measure to be taken.

1. Without prejudice to the existing national provisions and practices on

medical confidentiality, CLAA shall ensure that all the Parties involved in the

application of this Schedule M III are bound to observe confidentiality with regard

to all information obtained in carrying out their tasks. This does not affect the

obligation of CLAA and notified bodies with regard to mutual information and the

dissemination of warnings, nor the obligations of the persons concerned to

provide information under criminal law.

2. The following information shall not be treated as confidential:

(a) information on the registration of persons responsible for placing devices

on the market in accordance with Schedule;

(b) information to users sent out by the manufacturer, authorized

representative or distributor in relation to a measure according to Schedule

(c) information contained in certificates issued, modified, supplemented,

suspended or withdrawn.

3. The measures designed to amend non-essential elements of this

Schedule M III inter-alia by supplementing it, relating to determination of the

conditions under which other information may be made publicly available, and in

particular for Class D and above devices to any obligation for manufacturers to

prepare and make available a summary of the information and data related to the

device, shall be adopted in accordance with the regulatory procedure with

scrutiny referred to in Schedule and D&C Act.

1. The devices must be designed and manufactured in such a way that,

when used under the conditions and for the purposes intended, they will not

compromise the clinical condition or the safety of patients, or the safety and

health of users or, where applicable, other persons, provided that any risks which

may be associated with their use constitute acceptable risks when weighed

against the benefits to the patient and are compatible with a high level of

protection of health and safety.

2. The solutions adopted by the manufacturer for the design and

construction of the devices must conform to safety principles, taking account of

the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer must apply the

following principles in the following order:

- eliminate or reduce risks as far as possible (inherently safe design and

construction),

- where appropriate take adequate protection measures including alarms if

necessary, in relation to risks that cannot be eliminated,

- inform users of the residual risks due to any shortcomings of the protection

measures adopted.

3. The devices must achieve the performances intended by the

manufacturer and be designed, manufactured and packaged in such a way that

they are suitable for one or more of the functions referred to in Article 1 (2) (a), as

specified by the manufacturer.

4. The characteristics and performances referred to in Sections 1, 2 and 3

must not be adversely affected to such a degree that the clinical conditions and

safety of the patients and, where applicable, of other persons are compromised

during the lifetime of the device as indicated by the manufacturer, when the

device is subjected to the stresses which can occur during normal conditions of

use.

5. The devices must be designed, manufactured and packed in such a way

that their characteristics and performances during their intended use will not be

adversely affected during transport and storage taking account of the instructions

and information provided by the manufacturer.

6. Any undesirable side-effect must constitute an acceptable risk when

weighed against the performances intended.

7. Chemical, physical and biological properties

7.1. The devices must be designed and manufactured in such a way as to

guarantee the characteristics and performances referred to in Section I on the

'General requirements'. Particular attention must be paid to:

- the choice of materials used, particularly as regards toxicity and, where

appropriate, flammability,

- the compatibility between the materials used and biological tissues, cells

and body fluids, taking account of the intended purpose of the device.

7.2. The devices must be designed, manufactured and packed in such a

way as to minimize the risk posed by contaminants and residues to the persons

involved in the transport, storage and use of the devices and to the patients,

taking account of the intended purpose of the product. Particular attention must

be paid to the tissues exposed and to the duration and frequency of exposure.

7.3. The devices must be designed and manufactured in such a way that

they can be used safely with the materials, substances and gases with which

they enter into contact during their normal use or during routine procedures; if the

devices are intended to administer medicinal products they must be designed

and manufactured in such a way as to be compatible with the medicinal products

concerned according to the provisions and restrictions governing these products

and that their performance is maintained in accordance with the intended use.

7.4. Where a device incorporates, as an integral part, a substance which, if

used separately, may be considered to be a medicinal product and which is liable

to act upon the body with action ancillary to that of the device, the safety, quality

and usefulness of the substance must be verified, taking account of the intended

purpose of the device, by analogy with the appropriate methods.

7.5. The devices must be designed and manufactured in such a way as to

reduce to a minimum the risks posed by substances leaking from the device.

7.6. Devices must be designed and manufactured in such a way as to

reduce, as much as possible, risks posed by the unintentional ingress of

substances into the device taking into account the device and the nature of the

environment in which it is intended to be used.

8. Infection and microbial contamination

8.1. The devices and manufacturing processes must be designed in such a

way as to eliminate or reduce as far as possible the risk of infection to the patient,

user and third parties. The design must allow easy handling and, where

necessary, minimize contamination of the device by the patient or vice versa

during use.

8.2. Tissues of animal origin must originate from animals that have been

subjected to veterinary controls and surveillance adapted to the intended use of

the tissues.

Notified bodies shall retain information on the geographical origin of the

animals.

Processing, preservation, testing and handling of tissues, cells and

substances of animal origin must be carried out so as to provide optimal security.

In particular safety with regard to viruses and other transferable agents must be

addressed by implementation of validated methods of elimination or viral

inactivation in the course of the manufacturing process.

8.3. Devices delivered in a sterile state must be designed, manufactured

and packed in a non-reusable pack and/or according to appropriate procedures

to ensure that they are sterile when placed on the market and remain sterile,

under the storage and transport conditions laid down, until the protective

packaging is damaged or opened.

8.4. Devices delivered in a sterile state must have been manufactured and

sterilized by an appropriate, validated method.

8.5. Devices intended to be sterilized must be manufactured in appropriately

controlled (e. g. environmental) conditions.

8.6. Packaging systems for non-sterile devices must keep the product

without deterioration at the level of cleanliness stipulated and, if the devices are

to be sterilized prior to use, minimize the risk of microbial contamination; the

packaging system must be suitable taking account of the method of sterilization

indicated by the manufacturer.

8.7. The packaging and/or label of the device must distinguish between

identical or similar products sold in both sterile and non-sterile condition.

9. Construction and environmental properties

9.1. If the device is intended for use in combination with other devices or

equipment, the whole combination, including the connection system must be safe

and must not impair the specified performances of the devices. Any restrictions

on use must be indicated on the label or in the instructions for use.

9.2. Devices must be designed and manufactured in such a way as to

remove or minimize as far as is possible:

- the risk of injury, in connection with their physical features, including the

volume/pressure ratio, dimensional and where appropriate ergonomic features,

- risks connected with reasonably foreseeable environmental conditions,

such as magnetic fields, external electrical influences, electrostatic discharge,

pressure, temperature or variations in pressure and acceleration,

- the risks of reciprocal interference with other devices normally used in the

investigations or for the treatment given,

- risks arising where maintenance or calibration are not possible (as with

implants), from ageing of materials used or loss of accuracy of any measuring or

control mechanism.

9.3. Devices must be designed and manufactured in such a way as to

minimize the risks of fire or explosion during normal use and in single fault

condition. Particular attention must be paid to devices whose intended use

includes exposure to flammable substances or to substances which could cause

combustion.

10. Devices with a measuring function

10.1. Devices with a measuring function must be designed and

manufactured in such a way as to provide sufficient accuracy and stability within

appropriate limits of accuracy and taking account of the intended purpose of the

device. The limits of accuracy must be indicated by the manufacturer.

10.2. The measurement, monitoring and display scale must be designed in

line with ergonomic principles, taking account of the intended purpose of the

device.

10.3. The measurements made by devices with a measuring function must

be expressed in legal units conforming to the provisions of Weights and

Measures Act 1977.

11. Protection against radiation

11.1. General

11.1.1. Devices shall be designed and manufactured in such a way that

exposure of patients, users and other persons to radiation shall be reduced as far

as possible compatible with the intended purpose, whilst not restricting the

application of appropriate specified levels for therapeutic and diagnostic

purposes.

11.2. Intended radiation

11.2.1. Where devices are designed to emit hazardous levels of radiation

necessary for a specific medical purpose the benefit of which is considered to

outweigh the risks inherent in the emission, it must be possible for the user to

control the emissions. Such devices shall be designed and manufactured to

ensure reproducibility and tolerance of relevant variable parameters.

11.2.2. Where devices are intended to emit potentially hazardous, visible

and/or invisible radiation, they must be fitted, where practicable, with visual

displays and/or audible warnings of such emissions.

11.3. Unintended radiation

11.3.1. Devices shall be designed and manufactured in such a way that

exposure of patients, users and other persons to the emission of unintended,

stray or scattered radiation is reduced as far as possible.

11.4. Instructions

11.4.1. The operating instructions for devices emitting radiation must give

detailed information as to the nature of the emitted radiation, means of protecting

the patient and the user and on ways of avoiding misuse and of eliminating the

risks inherent in installation.

11.5. Ionizing radiation

11.5.1. Devices intended to emit ionizing radiation must be designed and

manufactured in such a way as to ensure that, where practicable, the quantity,

geometry and quality of radiation emitted can be varied and controlled taking into

account the intended use.

11.5.2. Devices emitting ionizing radiation intended for diagnostic radiology

shall be designed and manufactured in such a way as to achieve appropriate

image and/or output quality for the intended medical purpose whilst minimizing

radiation exposure of the patient and user.

11.5.3. Devices emitting ionizing radiation, intended for therapeutic

radiology shall be designed and manufactured in such a way as to enable reliable

monitoring and control of the delivered dose, the beam type and energy and

where appropriate the quality of radiation.

12. Requirements for medical devices connected to or equipped with an

energy source

12.1. Devices incorporating electronic programmable systems must be

designed to ensure the repeatability, reliability and performance of these systems

according to the intended use. In the event of a single fault condition (in the

system) appropriate means should be adopted to eliminate or reduce as far as

possible consequent risks.

12.2. Devices where the safety of the patients depends on an internal power

supply must be equipped with a means of determining the state of the power

supply.

12.3. Devices where the safety of the patients depends on an external

power supply must include an alarm system to signal any power failure.

12.4. Devices intended to monitor one or more clinical parameters of a

patient must be equipped with appropriate alarm systems to alert the user of

situations which could lead to death or severe deterioration of the patient's state

of health.

12.5. Devices must be designed and manufactured in such a way as to

minimize the risks of creating electromagnetic fields which could impair the

operation of other devices or equipment in the usual environment.

12.6. Protection against electrical risks

Devices must be designed and manufactured in such a way as to avoid, as

far as possible, the risk of accidental electric shocks during normal use and in

single fault condition, provided the devices are installed correctly.

12.7. Protection against mechanical and thermal risks

12.7.1. Devices must be designed and manufactured in such a way as to

protect the patient and user against mechanical risks connected with, for

example, resistance, stability and moving parts.

12.7.2. Devices must be designed and manufactured in such a way as to

reduce to the lowest possible level the risks arising from vibration generated by

the devices, taking account of technical progress and of the means available for

limiting vibrations, particularly at source, unless the vibrations are part of the

specified performance.

12.7.3. Devices must be designed and manufactured in such a way as to

reduce to the lowest possible level the risks arising from the noise emitted, taking

account of technical progress and of the means available to reduce noise,

particularly at source, unless the noise emitted is part of the specified

performance.

12.7.4. Terminals and connectors to the electricity, gas or hydraulic and

pneumatic energy supplies which the user has to handle must be designed and

constructed in such a way as to minimize all possible risks.

12.7.5. Accessible parts of the devices (excluding the parts or areas

intended to supply heat or reach given temperatures) and their surroundings

must not attain potentially dangerous temperatures under normal use.

12.8. Protection against the risks posed to the patient by energy supplies or

substances

12.8.1. Devices for supplying the patient with energy or substances must be

designed and constructed in such a way that the flow-rate can be set and

maintained accurately enough to guarantee the safety of the patient and of the

user.

12.8.2. Devices must be fitted with the means of preventing and/or

indicating any inadequacies in the flow-rate which could pose a danger.

Devices must incorporate suitable means to prevent, as far as possible, the

accidental release of dangerous levels of energy from an energy and/or

substance source.

12.9. The function of the controls and indicators must be clearly specified on

the devices.

Where a device bears instructions required for its operation or indicates

operating or adjustment parameters by means of a visual system, such

information must be understandable to the user and, as appropriate, the patient.

13. Information to be submitted by the manufacturer

13.1. Each device must be accompanied by the information needed to use it

safely and to identify the manufacturer, taking account of the training and

knowledge of the potential users.

This information comprises the details on the label and the data in the

instructions for use.

As far as practicable and appropriate, the information needed to use the

device safely must be set out on the device itself and/or on the packaging for

each unit or, where appropriate, on the sales packaging. If individual packaging

of each unit is not practicable, the information must be set out in the leaflet

supplied with one or more devices.

Instructions for use must be included in the packaging for every device. By

way of exception, no such instructions for use are needed for devices in Class A

or B if they can be used safely without any such instructions.

13.2. Where appropriate, this information should take the form of symbols.

Any symbol or identification colour used must conform to the harmonized

standards. In areas for which no standards exist, the symbols and colours must

be described in the documentation supplied with the device.

13.3. The label must bear the following particulars: Also adhere to RULE 96

(a) the name or trade name and address of the manufacturer. For devices

imported into the Country, in view of their distribution in the Country, the label, or

the outer packaging, or instructions for use, shall contain in addition the name

and address of either the Authorized Agent responsible or of the authorized

representative of the manufacturer established within the Country or of the

importer established within the Country, as appropriate;

(b) the details strictly necessary for the user to identify the device and the

contents of the packaging;

(c) where appropriate, the word 'STERILE';

(d) where appropriate, the batch code, preceded by the word 'LOT', or the

serial number;

(e) where appropriate, an indication of the date by which the device should

be used, in safety, expressed as the year and month;

(f) where appropriate, an indication that the device is for single use;

(g) if the device is costum-made, the words 'custom-made device';

(h) if the device is intended for clinical investigations, the words 'exclusively

for clinical investigations';

(i) any special storage and/or handling conditions;

(j) any special operating instructions;

(k) any warnings and/or precautions to take;

(l) year of manufacture for active devices other than those covered by (e).

This indication may be included in the batch or serial number;

(m) where applicable, method of sterilization.

13.4. If the intended purpose of the device is not obvious to the user, the

manufacturer must clearly state it on the label and in the instructions for use.

13.5. Wherever reasonable and practicable, the devices and detachable

components must be identified, where appropriate in terms of batches, to allow

all appropriate action to detect any potential risk posed by the devices and

detachable components.

13.6. Where appropriate, the instructions for use must contain the following

particulars:

(a) the details referred to in Section 13.3, with the exception of (d) and (e);

(b) any undesirable side-effects;

(c) if the device must be installed with or connected to other medical devices

or equipment in order to operate as required for its intended purpose, sufficient

details of its characteristics to identify the correct devices or equipment to use in

order to obtain a safe combination;

(d) all the information needed to verify whether the device is properly

installed and can operate correctly and safely, plus details of the nature and

frequency of the maintenance and calibration needed to ensure that the devices

operate properly and safely at all times;

(e) where appropriate, information to avoid certain risks in connection with

implantation of the device;

(f) information regarding the risks of reciprocal interference posed by the

presence of the device during specific investigations or treatment;

(g) the necessary instructions in the event of damage to the sterile

packaging and, where appropriate, details of appropriate methods of

resterilization;

(h) if the device is reusable, information on the appropriate processes to

allow reuse, including cleaning, disinfection, packaging and, where appropriate,

the method of sterilization of the device to be resterilized, and any restriction on

the number of reuses.

Where devices are supplied with the intention that they be sterilized before

use, the instructions for cleaning and sterilization must be such that, if correctly

followed, the device will still comply with the requirements in Section I;

(i) details of any further treatment or handling needed before the device can

be used (for example, sterilization, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes, details of

the nature, type, intensity and distribution of this radiation.

The instructions for use must also include details allowing the medical staff

to brief the patient on any contra-indications and any precautions to be taken.

These details should cover in particular:

(k) precautions to be taken in the event of changes in the performance of

the device;

(l) precautions to be taken as regards exposure, in reasonably foreseeable

environmental conditions, to magnetic fields, external electrical influences,

electrostatic discharge, pressure or variations in pressure, acceleration, thermal

ignition sources, etc.;

(m) adequate information regarding the medicinal product or products which

the device in question is designed to administer, including any limitations in the

choice of substances to be delivered;

(n) precautions to be taken against any special, unusual risks related to the

disposal of the device;

(o) medicinal substances incorporated into the device as an integral part in

accordance with Section 7.4;

(p) degree of accuracy claimed for devices with a measuring function.

14. Where conformity with the essential requirements must be based on

clinical data, such data must be established in accordance with Annex X.

1. The manufacturer must ensure application of the quality system approved

for the design, manufacture and final inspection of the products concerned, as

specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 4

and to surveillance as specified in Section 5.

2. The declaration of conformity is the procedure whereby the manufacturer

who fulfils the obligations imposed by Section 1 ensures and declares that the

products concerned meet the provisions of this Schedule which apply to them.

The manufacturer must affix the ICA marking in and draw up a written

declaration of conformity. This declaration must cover a given number of the

products manufactured and be kept by the manufacturer.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his

quality system with a notified body and must submit a copy of under-mentioned

documents to the competent authority in case of Class C and D devices.

The application must include:

- the name and address of the manufacturer and any additional

manufacturing site covered by the quality system,

- all the relevant information on the product or product category covered by

the procedure,

- a written declaration that no application has been lodged with any other

notified body for the same product-related quality system,

- the documentation on the quality system,

- an undertaking by the manufacturer to fulfil the obligations imposed by the

quality system approved,

- an undertaking by the manufacturer to keep the approved quality system

adequate and efficacious,

- an undertaking by the manufacturer to institute and keep up to date a

systematic procedure to review experience gained from devices in the postproduction

phase and to implement appropriate means to apply any necessary

corrective action. This undertaking must include an obligation for the

manufacturer to notify the competent authorities of the following incidents

immediately on learning of them:

(i) any malfunction or deterioration in the characteristics and/or performance

of a device, as well as any inadequacy in the instructions for use which might

lead to or might have led to the death of a patient or user or to a serious

deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics or

performance of a device leading for the reasons referred to in subparagraph (i) to

systematic recall of devices of the same type by the manufacturer.

3.2. Application of the quality system must ensure that the products conform

to the provisions of this Schedule which apply to them at every stage, from

design to final inspection. All the elements, requirements and provisions adopted

by the manufacturer for his quality system must be documented in a systematic

and orderly manner in the form of written policies and procedures such as quality

programmes, quality plans, quality manuals and quality records.

It shall include in particular an adequate description of:

(a) the manufacturer's quality objectives;

(b) the organization of the business and in particular:

- the organizational structures, the responsibilities of the managerial staff

and their organizational authority where quality of design and manufacture of the

products is concerned,

- the methods of monitoring the efficient operation of the quality system and

in particular its ability to achieve the desired quality of design and of product,

including control of products which fail to conform;

(c) the procedures for monitoring and verifying the design of the products

and in particular:

- a general description of the product, including any variants planned,

- the design specifications, including the standards which will be applied and

the results of the risk analysis, and also a description of the solutions adopted to

fulfil the essential requirements which apply to the products if the standards

referred to in Article 5 are not applied in full,

- the techniques used to control and verify the design and the processes

and systematic measures which will be used when the products are being

designed,

- if the device is to be connected to other device(s) in order to operate as

intended, proof must be provided that it conforms to the essential requirements

when connected to any such device(s) having the characteristics specified by the

manufacturer,

- a statement indicating whether or not the device incorporates, as an

integral part, a substance as referred to in Section 7.4 of Annex I and data on the

tests conducted in this connection,

- the clinical data referred to in Annex ,

- the draft label and, where appropriate, instructions for use;

(d) the inspection and quality assurance techniques at the manufacturing

stage and in particular:

- the processes and procedures which will be used, particularly as regards

sterilization, purchasing and the relevant documents,

- the product identification procedures drawn up and kept up to date from

drawings, specifications or other relevant documents at every stage of

manufacture;

(e) the appropriate tests and trials which will be carried out before, during

and after manufacture, the frequency with which they will take place, and the test

equipment used; it must be possible to trace back the calibration of the test

equipment adequately.

3.3. The notified body must audit the quality system to determine whether it

meets the requirements referred to in Section 3.2. It must verify that quality

systems which implement the relevant harmonized standards conform to these

requirements.

The assessment team must include at least one member with past

experience of assessments of the technology concerned. The assessment

procedure must include an inspection on the manufacturer's premises and, in

duly substantiated cases, on the premises of the manufacturer's suppliers and/or

subcontractors to inspect the manufacturing processes.

The decision is notified to the manufacturer. It must contain the conclusions

of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved the

quality system of any plan for substantial changes to the quality system or the

product-range covered. The notified body must assess the changes proposed

and verify whether after these changes the quality system still meets the

requirements referred to in Section 3.2. It must notify the manufacturer of its

decision. This decision must contain the conclusions of the inspection and a

reasoned assessment.

4. Examination of the design of the product

4.1. In addition to the obligations imposed by Section 3, the manufacturer

must lodge with the notified body an application for examination of the design

dossier relating to the product which he plans to manufacture and which falls into

the category referred to in Section 3.1.

4.2. The application must describe the design, manufacture and

performances of the product in question. It must include the documents needed

to assess whether the product conforms to the requirements of this schedule, as

referred to in Section 3.2 (c).

4.3. The notified body must examine the application and, if the product

conforms to the relevant provisions of this Schedule, issue the application with an

design-examination certificate. The notified body may require the application to

be completed by further tests or proof to allow assessment of conformity with the

requirements of the Schedule. The certificate must contain the conclusions of the

examination, the conditions of validity, the data needed for identification of the

approved design, where appropriate, a description of the intended purpose of the

product.

In the case of devices referred to in Annex I, paragraph 7.4, the notified

body shall, in view of the aspects addressed in that paragraph, consult one of the

competent bodies in the country before taking a decision.

The notified body will give due consideration to the views expressed in this

consultation when making its decision. It will convey its final decision to the

competent body concerned.

4.4. Changes to the approved design must receive further approval from the

notified body which issued the design-examination certificate wherever the

changes could affect conformity with the essential requirements of the Schedule

or with the conditions prescribed for use of the product. The applicant shall inform

the notified body which issued the design-examination certificate of any such

changes made to the approved design. This additional approval must take the

form of a supplement to the ICA design-examination certificate.

5. Surveillance

5.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the

obligations imposed by the approved quality system.

5.2. The manufacturer must authorize the notified body to carry out all the

necessary inspections and supply it with all relevant information, in particular:

- the documentation on the quality system,

- the data stipulated in the part of the quality system relating to design, such

as the results of analyses, calculation tests, etc.,

- the data stipulated in the part of the quality system relating to manufacture,

such as inspection reports and test data, calibration data, qualification reports of

the personnel concerned, etc.

5.3. The notified body must periodically carry out appropriate inspections

and assessments to make sure that the manufacturer applies the approved

quality system and must supply the manufacturer with an assessment report.

5.4. In addition, the notified body may pay unannounced visits to the

manufacturer. At the time of such visits, the notified body may, where necessary,

carry out or ask for tests in order to check that the quality system is working

properly. It must provide the manufacturer with an inspection report and, if a test

has been carried out, with a test report.

6. Administrative provisions

6.1. The manufacturer must, for a period ending at least five years after the

last product has been manufactured, keep at the disposal of the national

authorities:

- the declaration of conformity,

- the documentation referred to in the fourth indent of Section 3.1,

- the changes referred to in Section 3.4,

- the documentation referred to in Section 4.2, and

- the decisions and reports from the notified body as referred to in Sections

3.3, 4.3, 4.4, 5.3 and 5.4.

6.2. The notified body must make available to the other notified bodies and

the competent authority, on request, all relevant information concerning quality

system approvals issued, refused or withdrawn.

6.3. In respect of devices subject to the procedure in Section 4, when

neither the manufacturer nor his authorized representative, the obligation to keep

available the technical documentation shall fall to the person responsible for

placing the device on the market or the importer referred to in Annex I, Section

13.3 (a).

7. Application to devices in Classes B and C

This Annex may apply to products in Classes A and B. Section 4, however,

does not apply.

1. Type-examination is the procedure whereby a notified body ascertains

and certifies that a representative sample of the production covered fulfils the

relevant provisions of this Schedule.

2. The application includes:

- the name and address of the manufacturer and the name and address of

the authorized representative if the application is lodged by the representative,

- the documentation described in Section 3 needed to assess the conformity

of the representative sample of the production in question, hereinafter referred to

as the 'type', with the requirements of this Schedule. The applicant must make a

'type' available to the notified body. The notified body may request other samples

as necessary,

- a written declaration that no application has been lodged with any other

notified body for the same type.

3. The documentation must allow an understanding of the design, the

manufacture and the performances of the product and must contain the following

items in particular:

- a general description of the type, including any variants planned,

- design drawings, methods of manufacture envisaged, in particular as

regards sterilization, and diagrams of components, sub-assemblies, circuits, etc.,

- the descriptions and explanations necessary to understand the

abovementioned drawings and diagrams and the operation of the product,

- a list of the standards referred to in Article 5, applied in full or in part, and

descriptions of the solutions adopted to meet the essential requirements if the

standards referred to in Article 5 have not been applied in full,

- the results of the design calculations, risk analysis, investigations,

technical tests, etc. carried out,

- a statement indicating whether or not the device incorporates, as an

integral part, a substance as referred to in Section 7.4 of Annex I and data on the

tests conducted in this connection,

- the clinical data referred to in Annex ,

- the draft label and, where appropriate, instructions for use.

4. The notified body must:

4.1. examine and assess the documentation and verify that the type has

been manufactured in conformity with that documentation; it must also record the

items designed in conformity with the applicable provisions of the standards

referred to in Article 5, as well as the items not designed on the basis of the

relevant provisions of the abovementioned standards;

4.2. carry out or arrange for the appropriate inspections and the tests

necessary to verify whether the solutions adopted by the manufacturer meet the

essential requirements of this Schedule if the standards referred to in Article 5

have not been applied; if the device is to be connected to other device(s) in order

to operate as intended, proof must be provided that it conforms to the essential

requirements when connected to any such device(s) having the characteristics

specified by the manufacturer;

4.3. carry out or arrange for the appropriate inspections and the tests

necessary to verify whether, if the manufacturer has chosen to apply the relevant

standards, these have actually been applied;

4.4. agree with the applicant on the place where the necessary inspections

and tests will be caried out.

5. If the type conforms to the provisions of this Schedule, the notified body

issues the applicant with an ICA type-examination certificate. The certificate must

contain the name and address of the manufacturer, the conclusions of the

inspection, the conditions of validity and the data needed for identification of the

type approved. The relevant parts of the documentation must be annexed to the

certificate and a copy kept by the notified body.

In the case of devices referred to in Annex I, paragraph 7.4, the notified

body shall, in view of the aspects addressed in that paragraph, consult one of the

competent bodies established in the country before taking a decision.

The notified body will give due consideration to the views expressed in this

consultation when making its decision. It will convey its final decision to the

competent body concerned.

6. The applicant must inform the notified body which issued the typeexamination

certificate of any significant change made to the approved product.

Changes to the approved product must receive further approval from the

notified body which issued the ICA type-examination certificate wherever the

changes may affect conformity with the essential requirements or with the

conditions prescribed for use of the product. This new approval must, where

appropriate, take the form of a supplement to the initial ICA type-examination

certificate.

7. Administrative provisions

7.1. The notified body must make available to the other notified bodies on

request, all relevant information on ICA type-examination certificates and

supplements issued, refused or withdrawn.

7.2. Other notified bodies may obtain a copy of the ICA type-examination

certificates and/or the supplements thereto. The Annexes to the certificates must

be made available to other notified bodies on reasoned application, after the

manufacturer has been informed.

7.3. The manufacturer or his authorized representative must keep with the

technical documentation copies of ICA type-examination certificates and their

additions for a period ending at least five years after the last device has been

manufactured.

7.4. When neither the manufacturer nor his authorized representative

approved in the Country, the obligation to keep available the technical

documentation shall fall to the person responsible for placing the device on the

Indian market or the importer referred to in Annex I, Section 13.3 (a).

1. ICAC verification is the procedure whereby the manufacturer or his

authorized representative established in the Country ensures and declares that

the products which have been subject to the procedure set out in Section 4

conform to the type described in the IC type-examination certificate and meet the

requirements of this Schedule which apply to them.

2. The manufacturer must take all the measures necessary to ensure that

the manufacturing process produces products which conform to the type

described in the IC type-examination certificate and to the requirements of the

Schedule which apply to them. Before the start of manufacture, the manufacturer

must prepare documents defining the manufacturing process, in particular as

regards sterilization where necessary, together with all the routine, preestablished

provisions to be implemented to ensure homogeneous production

and, where appropriate, conformity of the products with the type described in the

IC type-examination certificate and with the requirements of this Schedule which

apply to them. The manufacturer must affix the ICA marking in accordance with

Article 17 and draw up a declaration of conformity.

In addition, for products placed on the market in sterile condition, and only

for those aspects of the manufacturing process designed to secure and maintain

sterility, the manufacturer must apply the provisions of Annex V, Sections 3 and

4.

3. The manufacturer must undertake to institute and keep up to date a

systematic procedure to review experience gained from devices in the postproduction

phase and to implement appropriate means to apply any necessary

corrective action. This undertaking must include an obligation for the

manufacturer to notify the competent authorities of the following incidents

immediately on learning of them:

(i) any malfunction or deterioration in the characteristics and/or performance

of a device, as well as any inadequacy in the labelling or the instructions for use

which might lead to or might have led to the death of a patient or user or to a

serious deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics or

performance of a device for the reasons referred to in subparagraph (i) leading to

systematic recall of devices of the same type by the manufacturer.

4. The notified body must carry out the appropriate examinations and tests

in order to verify the conformity of the product with the requirements of the

Schedule either by examining and testing every product as specified in Section 5

or by examining and testing products on a statistical basis as specified in Section

6, as the manufacturer decides.

The aforementioned checks do not apply to those aspects of the

manufacturing process designed to secure sterility.

5. Verification by examination and testing of every product

5.1. Every product is examined individually and the appropriate tests defined

in the relevant standard(s) referred to in Article 5 or equivalent tests must be

carried out in order to verify, where appropriate, the conformity of the products

with the IC type described in the type-examination certificate and with the

requirements of the Schedule which apply to them.

5.2. The notified body must affix, or have affixed its identification number to

each approved product and must draw up a written certificate of conformity

relating to the tests carried out.

6. Statistical verification

6.1. The manufacturer must present the manufactured products in the form

of homogeneous batches.

6.2. A random sample is taken from each batch. The products which make

up the sample are examined individually and the appropriate tests defined in the

relevant standard(s) referred to in Article 5 or equivalent tests must be carried out

to verify, where appropriate, the conformity of the products with the type

described in the IC type-examination certificate and with the requirements of the

Schedule which apply to them in order to determine whether to accept or reject

the batch.

6.3. Statistical control of products will be based on attributes, entailing a

sampling system ensuring a limit quality corresponding to a probability of

acceptance of 5 %, with a non-conformity percentage of between 3 and 7 %. The

sampling method will be established by the harmonized standards referred to in

Article 5, taking account of the specific nature of the product categories in

question.

6.4. If the batch is accepted, the notified body affixes or has affixed its

identification number to each product and draws up a written certificate of

conformity relating to the tests carried out. All products in the batch may be put

on the market except any in the sample which failed to conform.

If a batch is rejected, the competent notified body must take appropriate

measures to prevent the batch from being placed on the market. In the event of

frequent rejection of batches, the notified body may suspend the statistical

verification.

The manufacturer may, on the responsibility of the notified body, affix the

notified body's identification number during the manufacturing process.

7. Administrative provisions

The manufacturer or his authorized representative must, for a period ending

at least five years after the last product has been manufactured, make available

to the CLAA:

- the declaration of conformity,

- the documentation referred to in Section 2,

- the certificates referred to in Sections 5.2 and 6.4,

- where appropriate, the type-examination certificate referred to in Annex III.

8. Application to devices in Class B

In line with Article 11 (2), this Annex may apply to products in Class B,

subject to the following exemptions:

8.1. in derogation from Sections 1 and 2, by virtue of the declaration of

conformity the manufacturer ensures and declares that the products in Class B

are manufactured in conformity with the technical documentation referred to in

Section 3 of Annex VII and meet the requirements of this Schedule which apply

to them;

8.2. in derogation from Sections 1, 2, 5 and 6, the verifications conducted by

the notified body are intended to confirm the conformity of the products in Class B

with the technical documentation referred to in Section 3 of Annex VII.

1. The manufacturer must ensure application of the quality system approved

for the manufacture of the products concerned and carry out the final inspection,

as specified in Section 3, and is subject to the surveillance referred to in Section

4.

2. The declaration of conformity is the part of the procedure whereby the

manufacturer who fulfils the obligations imposed by Section 1 ensures and

declares that the products concerned conform to the type described in the EC

type-examination certificate and meets the provisions of this Schedule which

apply to them.

The manufacturer must affix the ICA marking in accordance with Article 17

and draw up a written declaration of conformity. This declaration must cover a

given number of identified specimens of the products manufactured and must be

kept by the manufacturer.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his

quality system with a notified body.

The application must include:

- the name and address of the manufacturer,

- all the relevant information on the product or product category covered by

the procedure,

- a written declaration that no application has been lodged with any other

notified body for the same products,

- the documentation on the quality system,

- an undertaking to fulfil the obligations imposed by the quality system is

approved,

- an undertaking to maintain the practicability and effectiveness of the

approved quality system,

- where appropriate, the technical documentation on the types approved and

a copy of the IC type-examination certificates,

- an undertaking by the manufacturer to institute and keep up to date a

systematic procedure to review experience gained from devices in the postproduction

phase and to implement appropriate means to apply any necessary

corrective action. This undertaking must include an obligation for the

manufacturer to notify the competent authorities of the following incidents

immediately on learning of them:

(i) any malfunction or deterioration in the characteristics and/or performance

of a device, as well as any inadequacy in the labelling or the instructions for use

which might lead to or might have led to the death of a patient or user or to a

serious deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics or

performance of a device for the reasons referred to in subparagraph (i) above

leading to a systematic recall of devices of the same type by the manufacturer.

3.2. Application of the quality system must ensure that the products conform

to the type described in the IC type-examination certificate.

All the elements, requirements and provisions adopted by the manufacturer

for his quality system must be documented in a systematic and orderly manner in

the form of written policy statements and procedures. This quality system

documentation must permit uniform interpretation of the quality policy and

procedures such as quality programmes, plans, manuals and records.

It must include in particular an adequate description of:

(a) the manufacturer's quality objectives;

(b) the organization of the business and in particular:

- the organizational structures, the responsibilities of the managerial staff

and their organizational authority where manufacture of the products is

concerned,

- the methods of monitoring the efficient operation of the quality system and

in particular its ability to achieve the desired quality of product, including control

of products which fail to conform;

(c) the inspection and quality assurance techniques at the manufacturing

stage and in particular:

- the processes and procedures which will be used, particularly as regards

sterilization, purchasing and the relevant documents,

- the product identification procedures drawn up and kept up to date from

drawings, specifications or other relevant documents at every stage of

manufacture;

(d) the appropriate tests and trials to be carried out before, during and after

manufacture, the frequency with which they will take place, and the test

equipment used; it must be possible adequately to trace back the calibration of

the test equipment.

3.3. The notified body must audit the quality system to determine whether it

meets the requirements referred to in Section 3.2. It must presume that quality

systems which implement the relevant harmonized standards conform to these

requirements.

The assessment team must include at least one member with past

experience of assessments of the technology concerned. The assessment

procedure must include an inspection on the manufacturer's premises and, in

duly substantiated cases, on the premises of the manufacturer's suppliers to

inspect the manufacturing processes.

The decision must be notified to the manufacturer after the final inspection

and contain the conclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved the

quality system of any plan for substantial changes to the quality system.

The notified body must assess the changes proposed and verify whether

after these changes the quality system still meets the requirements referred to in

Section 3.2.

After the abovementioned information has been received the decision is

notified to the manufacturer. It must contain the conclusions of the inspection and

a reasoned assessment.

4. Surveillance

4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the

obligations imposed by the approved quality system.

4.2. The manufacturer authorizes the notified body to carry out all the

necessary inspections and must supply it with all relevant information, in

particular:

- the documentation on the quality system,

- the data stipulated in the part of the quality system relating to manufacture,

such as inspection reports and test data, calibration data, qualification reports of

the personnel concerned, etc.

4.3. The notified body must periodically carry out appropriate inspections

and assessments to make sure that the manufacturer applies the approved

quality system and supply the manufacturer with an assessment report.

4.4. In addition, the notified body may pay unannounced visits to the

manufacturer. At the time of such visits, the notified body may, where necessary,

carry out or ask for tests in order to check that the quality system is working

properly. It must provide the manufacturer with an inspection report and, if a test

has been carried out, with a test report.

5. Administrative provisions

5.1. The manufacturer must, for a period ending at least five years after the

last product has been manufactured, make available to the national authorities:

- the declaration of conformity,

- the documentation referred to in the fourth indent of Section 3.1,

- the changes referred to in Section 3.4,

- the documentation referred to in the seventh indent of Section 3.1,

- the decisions and reports from the notified body as referred to in Sections

4.3 and 4.4,

- where appropriate, the type-examination certificate referred to in Annex III.

5.2. The notified body must make available to the other notified bodies, on

request, all relevant information concerning the quality system approvals issued,

refused or withdrawn.

6. Application to devices in Class B

In line with Article 11 (2), this Annex may apply to products in Class B,

subject to the following exemption:

6.1. in derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration

of conformity the manufacturer ensures and declares that the products in Class B

are manufactured in conformity with the technical documentation referred to in

Section 3 of Annex VII and meet the requirements of this Schedule which apply

to them.

1. The manufacturer must ensure application of the quality system approved

for the final inspection and testing of the product, as specified in Section 3 and

must be subject to the surveillance referred to in Section 4.

In addition, for products placed on the market in sterile condition, and only

for those aspects of the manufacturing process designed to secure and maintain

sterility, the manufacturer must apply the provisions of Annex V, Sections 3 and

4.

2. The declaration of conformity is the part of the procedure whereby the

manufacturer who fulfils the obligations imposed by Section 1 ensures and

declares that the products concerned conform to the type described in the IC

type-examination certificate and meet the provisions of this Schedule which apply

to them.

The manufacturer affixes the ICA marking in accordance with Article 17 and

draws up a written declaration of conformity. This declaration must cover a given

number of identified specimens of the products manufactured and be kept by the

manufacturer. The ICA marking must be accompanied by the identification

number of the notified body which performs the tasks referred to in this Annex.

3. Quality system

3.1. The manufacturer lodges an application for assessment of his quality

system with a notified body.

The application must include:

- the name and address of the manufacturer,

- all the relevant information on the product or product category covered by

the procedure,

- a written declaration specifying that no application has been lodged with

any other notified body for the same products,

- the documentation on the quality system,

- an undertaking by the manufacturer to fulfil the obligations imposed by the

quality system approved,

- an undertaking by the manufacturer to keep the approved quality system

adequate and efficacious,

- where appropriate, the technical documentation on the types approved and

a copy of the IC type-examination certificates,

- an undertaking by the manufacturer to institute and keep up to date a

systematic procedure to review experience gained from devices in the postproduction

phase and to implement appropriate means to apply any necessary

corrective action. This undertaking must include an obligation for the

manufacturer to notify the competent authorities of the following incidents

immediately on learning of them:

(i) any malfunction or deterioration in the characteristics and/or performance

of a device, as well as any inadequacy in the labelling or the instructions for use

which might lead to or might have led to the death of a patient or user or to a

serious deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics or the

performance of a device for the reasons referred to in subparagraph (i) leading to

a systematic recall of devices of the same type by the manufacturer.

3.2. Under the quality system, each product or a representative sample of

each batch is examined and the appropriate tests defined in the relevant

standard(s) referred to in Article 5 or equivalent tests are carried out to ensure

that the products conform to the type described in the IC type-examination

certificate and fulfil the provisions of this Schedule which apply to them. All the

elements, requirements and provisions adopted by the manufacturer must be

documented in a systematic and orderly manner in the form of written measures,

procedures and instructions. This quality system documentation must permit

uniform interpretation of the quality programmes, quality plans, quality manuals

and quality records.

It must include in particular an adequate description of:

- the quality objectives and the organizational structure, responsibilities and

powers of the managerial staff with regard to product quality,

- the examinations and tests that will be carried out after manufacture; it

must be possible to trace back the calibration of the test equipment adequately,

- the methods of monitoring the efficient operation of the quality system

- the quality records, such as reports concerning inspections, tests,

calibration and the qualifications of the staff concerned, etc.

The aforementioned checks do not apply to those aspects of the

manufacturing process designed to secure sterility.

3.3. The notified body audits the quality system to determine whether it

meets the requirements referred to in section 3.2. It must presume that quality

systems which implement the relevant harmonized standards conform to these

requirements.

The assessment team must include at least one member with past

experience of assessments of the technology concerned. The assessment

procedure must include an inspection on the manufacturer's premises and, in

duly substantiated cases, on the premises of the manufacturer's suppliers to

inspect the manufacturing processes.

The decision must be notified to the manufacturer. It must contain the

conclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved the

quality system of any plan for substantial changes to the quality system.

The notified body must assess the changes proposed and verify whether

after these changes the quality system will still meet the requirements referred to

in Section 3.2.

After receiving the abovementioned information it must notify the

manufacturer of its decision. This decision must contain the conclusions of the

inspection and a reasoned assessment.

4. Surveillance

4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the

obligations imposed by the approved quality system.

4.2. The manufacturer must allow the notified body access for inspection

purposes to the inspection, testing and storage locations and supply it with all

relevant information, in particular:

- the documentation on the quality system,

- the technical documentation,

- the quality records, such as inspection reports, test data, calibration data,

qualification reports of the staff concerned, etc.

4.3. The notified body must periodically carry out appropriate inspections

and assessments to make sure that the manufacturer applies the quality system

and must supply the manufacturer with an assessment report.

4.4. In addition, the notified body may pay unannounced visits to the

manufacturer. At the time of such visits, the notified body may, where necessary,

carry out or ask for tests in order to check that the quality system is working

properly and that the production conforms to the requirements of the Schedule

which apply to it. To this end, an adequate sample of the final products, taken on

site by the notified body, must be examined and the appropriate tests defined in

the relevant standard(s) referred to in Article 5 or equivalent tests must be carried

out. Where one or more of the samples fails to conform, the notified body must

take the appropriate measures.

It must provide the manufacturer with an inspection report and, if a test has

been carried out, with a test report.

5. Administrative provisions

5.1. The manufacturer must, for a period ending at least five years after the

last product has been manufactured, make available to the national authorities:

- the declaration of conformity,

- the documentation referred to in the seventh indent of Section 3.1,

- the changes referred to in Section 3.4,

- the decisions and reports from the notified body as referred to in the final

indent of Section 3.4 and in Sections 4.3 and 4.4,

- where appropriate, the certificate of conformity referred to in Annex III.

5.2. The notified body must make available to the other notified bodies, on

request, all relevant information concerning the quality system approvals issued,

refused or withdrawn.

6. Application to devices in Class B

In line with Article 11 (2), this Annex may apply to products in Class B,

subject to this derogation:

6.1. by derogation from Sections 2, 3.1 and 3.2 by virtue of the declaration

of conformity the manufacturer ensures and declares that the products in Class B

are manufactured in conformity with the technical documentation referred to in

Section 3 of Annex VII and meet the requirements of this Schedule which apply

to them.

1. The ICAC declaration of conformity is the procedure whereby the

manufacturer or his authorized representative fulfils the obligations imposed by

Section 2 and, in the case of products placed on the market in a sterile condition

and devices with a measuring function, the obligations imposed by Section 5

ensures and declares that the products concerned meet the provisions of this

Schedule which apply to them.

2. The manufacturer must prepare the technical documentation described in

Section 3. The manufacturer or his authorized representative must make this

documentation, including the declaration of conformity, available to notified

bodies for inspection purposes for a period ending at least five years after the last

product has been manufactured.

3. The technical documentation must allow assessment of the conformity of

the product with the requirements of the Schedule. It must include in particular:

- a general description of the product, including any variants planned,

- design drawings, methods of manufacture envisaged and diagrams of

components, sub-assemblies, circuits, etc.,

- the descriptions and explanations necessary to understand the

abovementioned drawings and diagrams and the operations of the product,

- the results of the risk analysis and a list of the standards referred to in

Article 5, applied in full or in part, and descriptions of the solutions adopted to

meet the essential requirements of the Schedule if the standards referred to in

Article 5 have not been applied in full,

- in the case of products placed on the market in a sterile condition,

description of the methods used,

- the results of the design calculations and of the inspections carried out,

etc.; if the device is to be connected to other device(s) in order to operate as

intended, proof must be provided that it conforms to the essential requirements

when connected to any such device(s) having the characteristics specified by the

manufacturer,

- the test reports and, where appropriate, clinical data in accordance with

Annex X,

- the label and instructions for use.

4. The manufacturer shall institute and keep up to date a systematic

procedure to review experience gained from devices in the post-production phase

and to implement appropriate means to apply any necessary corrective actions,

taking account of the nature and risks in relation to the product. He shall notify

the competent authorities of the following incidents immediately on learning of

them:

(i) any malfunction or deterioration in the characteristics and/or performance

of a device, as well as any inadequacy in the labelling or the instructions for use

which might lead to or might have led to the death of a patient or user or to a

serious deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics on the

performance of a device for the reasons referred to in subparagraph (i) leading to

systematic recall of devices of the same type by the manufacturer.

5. With products placed on the market in sterile condition and Class A

devices with a measuring function, the manufacturer must observe not only the

provisions laid down in this Annex but also one of the procedures referred to in

Annex IV, V or VI. Application of the abovementioned Annexes and the

intervention by the notified body is limited to:

- in the case of products placed on the market in sterile condition, only the

aspects of manufacture concerned with securing and maintaining sterile

conditions,

- in the case of devices with a measuring function, only the aspects of

manufacture concerned with the conformity of the products with the metrological

requirements.

Section 6.1. of this Annex is applicable.

6. Application to devices in Class B

In line with Article 11 (2), this Annex may apply to products in Class B,

subject to the following derogation:

6.1. where this Annex is applied in conjunction with the procedure referred

to in Annex IV, V or VI, the declaration of conformity referred to in the

abovementioned Annexes forms a single declaration. As regards the declaration

based on this Annex, the manufacturer must ensure and declare that the product

design meets the provisions of this Schedule which apply to it.

1. For custom-made devices or for devices intended for clinical

investigations the manufacturer or his authorized representative established in

the country must draw up the statement containing the information stipulated in

Section 2.

2. The statement must contain the following information:

2.1. for custom-made devices:

- data allowing identification of the device in question,

- a statement that the device is intended for exclusive use by a particular

patient, together with the name of the patient,

- the name of the medical practitioner or other authorized person who made

out the prescription and, where applicable, the name of the clinic concerned,

- the particular features of the device as specified in the relevant medical

prescription,

- a statement that the device in question conforms to the essential

requirements set out in Annex I and, where applicable, indicating which essential

requirements have not been fully met, together with the grounds;

2.2. for devices intended for the clinical investigations covered by Annex X:

- data allowing identification of the device in question,

- an investigation plan stating in particular the purpose, scientific, technical

or medical grounds, scope and number of devices concerned,

- the opinion of the ethics committee concerned and details of the aspects

covered by its opinion,

- the name of the medical practitioner or other authorized person and of the

institution responsible for the investigations,

- the place, starting date and scheduled duration for the investigations,

- a statement that the device in question conforms to the essential

requirements apart from the aspects covered by the investigations and that, with

regard to these aspects, every precaution has been taken to protect the health

and safety of the patient.

3. The manufacturer must also undertake to keep available for the

competent national authorities:

3.1. for custom-made devices, documentation allowing an understanding of

the design, manufacture and performances of the product, including the expected

performances, so as to allow assessment of conformity with the requirements of

this Schedule.

The manufacturer must take all the measures necessary to ensure that the

manufacturing process produces products which are manufactured in accordance

with the documentation mentioned in the first paragraph;

3.2. for devices intended for clinical investigations, the documentation must

contain:

- a general description of the product,

- design drawings, methods of manufacture envisaged, in particular as

regards sterilization, and diagrams of components, sub-assemblies, circuits, etc.,

- the descriptions and explanations necessary to understand the

abovementioned drawings and diagrams and the operation of the product,

- the results of the risk analysis and a list of the standards referred to in

Article 5, applied in full or in part, and descriptions of the solutions adopted to

meet the essential requirements of this Schedule if the standards referred to in

Article 5 have not been applied,

- the results of the design calculations, and of the inspections and technical

tests carried out, etc.

The manufacturer must take all the measures necessary to ensure that the

manufacturing process produces products which are manufactured in accordance

with the documentation referred to in the first paragraph of this Section.

The manufacturer must authorize the assessment, or audit where

necessary, of the effectiveness of these measures.

4. The information contained in the declarations concerned by this Annex

should be kept for a period of time of at least five years.

I. DEFINITIONS

1. Definitions for the classification rules

1.1. Duration

Transient

Normally intended for continuous use for less than 60 minutes.

Short term

Normally intended for continuous use for not more than 30 days.

Long term

Normally intended for continuous use for more than 30 days.

1.2. Invasive devices

Invasive device

A device which, in whole or in part, penetrates inside the body, either

through a body orifice or through the surface of the body.

Body orifice

Any natural opening in the body, as well as the external surface of the

eyeball, or any permanent artificial opening, such as a stoma.

Surgically invasive device

An invasive device which penetrates inside the body through the surface of

the body, with the aid or in the context of a surgical operation.

For the purposes of this Schedule devices other than those referred to in the

previous subparagraph and which produce penetration other than through an

established body orifice, shall be treated as surgically invasive devices.

Implantable device

Any device which is intended:

- to be totally introduced into the human body or,

- to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after the

procedure.

Any device intended to be partially introduced into the human body through

surgical intervention and intended to remain in place after the procedure for at

least 30 days is also considered an implantable device.

1.3. Reusable surgical instrument

Instrument intended for surgical use by cutting, drilling, sawing, scratching,

scraping, clamping, retracting, clipping or similar procedures, without connection

to any active medical device and which can be reused after appropriate

procedures have been carried out.

1.4. Active medical device

Any medical device operation of which depends on a source of electrical

energy or any source of power other than that directly generated by the human

body or gravity and which acts by converting this energy. Medical devices

intended to transmit energy, substances or other elements between an active

medical device and the patient, without any significant change, are not

considered to be active medical devices.

1.5. Active therapeutical device

Any active medical device, whether used alone or in combination with other

medical devices, to support, modify, replace or restore biological functions or

structures with a view to treatment or alleviation of an illness, injury or handicap.

1.6. Active device for diagnosis

Any active medical device, whether used alone or in combination with other

medical devices, to supply information for detecting, diagnosing, monitoring or

treating physiological conditions, states of health, illnesses or congenital

deformities.

II. IMPLEMENTING RULES 2. Implementing rules

2.1. Application of the classification rules shall be governed by the intended

purpose of the devices.

2.2. If the device is intended to be used in combination with another device,

the classification rules shall apply separately to each of the devices. Accessories

are classified in their own right separately from the device with which they are

used.

2.3. Software, which drives a device or influences the use of a device, falls

automatically in the same class.

2.4. If the device is not intended to be used solely or principally in a specific

part of the body, it must be considered and classified on the basis of the most

critical specified use.

2.5. If several rules apply to the same device, based on the performance

specified for the device by the manufacturer, the strictest rules resulting in the

higher classification shall apply.

III. CLASSIFICATION 1. Non-invasive devices

1.1. Rule 1

All non-invasive devices are in Class A, unless one of the rules set out

hereinafter applies.

1.2. Rule 2

All non-invasive devices intended for channelling or storing blood, body

liquids or tissues, liquids or gases for the purpose of eventual infusion,

administration or introduction into the body are in Class B:

- if they may be connected to an active medical device in Class A or a

higher class,

- if they are intended for use for storing or channelling blood or other body

liquids or for storing organs, parts of organs or body tissues,

in all other cases they are in Class A.

1.3. Rule 3

All non-invasive devices intended for modifying the biological or chemical

composition of blood, other body liquids or other liquids intended for infusion into

the body are in Class C, unless the treatment consists of filtration, centrifugation

or exchanges of gas, heat, in which case they are in Class B.

1.4. Rule 4

All non-invasive devices which come into contact with injured skin:

- are in Class A if they are intended to be used as a mechanical barrier, for

compression or for absorption of exudates,

- are in Class C if they are intended to be used principally with wounds

which have breached the dermis and can only heal by secondary intent,

- are in Class B in all other cases, including devices principally intended to

manage the micro-environment of a wound.

2. Invasive devices

2.1. Rule 5

All invasive devices with respect to body orifices, other than surgically

invasive devices and which are not intended for connection to an active medical

device:

- are in Class A if they are intended for transient use,

- are in Class B if they are intended for short-term use, except if they are

used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or

in a nasal cavity, in which case they are in Class A,

- are in Class C if they are intended for long-term use, except if they are

used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or

in a nasal cavity and are not liable to be absorbed by the mucous membrane, in

which case they are in Class B.

All invasive devices with respect to body orifices, other than surgically

invasive devices, intended for connection to an active medical device in Class B

or a higher class, are in Class B.

2.2. Rule 6

All surgically invasive devices intended for transient use are in Class B

unless they are:

- intended specifically to diagnose, monitor or correct a defect of the heart or

of the central circulatory system through direct contact with these parts of the

body, in which case they are in Class D,

- reusable surgical instruments, in which case they are in Class A,

- intended to supply energy in the form of ionizing radiation in which case

they are in Class C,

- intended to have a biological effect or to be wholly or mainly absorbed in

which case they are in Class C,

- intended to administer medicines by means of a delivery system, if this is

done in a manner that is potentially hazardous taking account of the mode of

application, in which they are in Class C.

2.3. Rule 7

All surgically invasive devices intended for short-term use are in Class B

unless they are intended:

- either specifically to diagnose, monitor or correct a defect of the heart or of

the central circulatory system through direct contact with these parts of the body,

in which case they are in Class D,

- or specifically for use in direct contact with the central nervous system, in

which case they are in Class D,

- or to supply energy in the form of ionizing radiation in which case they are

in Class C,

- or to have a biological effect or to be wholly or mainly absorbed in which

case they are in Class D,

- or to undergo chemical change in the body, except if the devices are

placed in the teeth, or to administer medicines, in which case they are in Class C.

2.4. Rule 8

All implantable devices and long-term surgically invasive devices are in

Class C unless they are intended:

- to be placed in the teeth, in which case they are in Class B,

- to be used in direct contact with the heart, the central circulatory system or

the central nervous system, in which case they are in Class D,

- to have a biological effect or to be wholly or mainly absorbed, in which

case they are in Class D,

- or to undergo chemical change in the body, except if the devices are

placed in the teeth, or to administer medicines, in which case they are in Class D.

3. Additional rules applicable to active devices

3.1. Rule 9

All active therapeutic devices intended to administer or exchange energy

are in Class B unless their characteristics are such that they may administer or

exchange energy to or from the human body in a potentially hazardous way,

taking account of the nature, the density and site of application of the energy, in

which case they are in Class C.

All active devices intended to control or monitor the performance of active

therapeutic devices in Class C, or intended directly to influence the performance

of such devices are in Class C.

3.2. Rule 10

Active devices intended for diagnosis are in Class B:

- if they are intended to supply energy which will be absorbed by the human

body, except for devices used to illuminate the patient's body, in the visible

spectrum,

- if they are intended to image in vivo distribution of radiopharmaceuticals,

- if they are intended to allow direct diagnosis or monitoring of vital

physiological processes, unless they are specifically intended for monitoring of

vital physiological parameters, where the nature of variations is such that it could

result in immediate danger to the patient, for instance variations in cardiac

performance, respiration, activity of CNS in which case they are in Class C.

Active devices intended to emit ionizing radiation and intended for

diagnostic and therapeutic interventional radiology including devices which

control or monitor such devices, or which directly influence their performance, are

in Class C.

Rule 11

All active devices intended to administer and/or remove medicines, body

liquids or other substances to or from the body are in Class B, unless this is done

in a manner:

- that is potentially hazardous, taking account of the nature of the

substances involved, of the part of the body concerned and of the mode of

application in which case they are in Class C.

3.3. Rule 12

All other active devices are in Class I.

4. Special Rules

4.1. Rule 13

All devices incorporating, as an integral part, a substance which, if used

separately, can be considered to be a medicinal product, and which is liable to

act on the human body with action ancillary to that of the devices, are in Class III.

4.2. Rule 14

All devices used for contraception or the prevention of the transmission of

sexually transmitted diseases are in Class C, unless they are implantable or long

term invasive devices, in which case they are in Class D.

4.3. Rule 15

All devices intended specifically to be used for disinfecting, cleaning, rinsing

or, when appropriate, hydrating contact lenses are in Class C.

All devices intended specifically to be used for disinfecting medical devices

are in Class B.

This rule does not apply to products that are intended to clean medical

devices other than contact lenses by means of physical action.

4.4. Rule 16

Non-active devices specifically intended for recording of X-ray diagnostic

images are in Class A.

4.5. Rule 17

All devices manufactured utilizing animal tissues or derivatives rendered

non-viable are Class D except where such devices are intended to come into

contact with intact skin only.

5. Rule 18

By derogation from other rules, blood bags are in Class C.

1. General provisions

1.1. As a general rule, confirmation of conformity with the requirements

concerning the characteristics and performances referred to in Sections 1 and 3

of Annex I under the normal conditions of use of the device and the evaluation of

the undesirable side-effects must be based on clinical data in particular in the

case of implantable devices and devices in Class D. Taking account of any

relevant harmonized standards, where appropriate, the adequacy of the clinical

data must be based on:

1.1.1. either a compilation of the relevant scientific literature currently

available on the intended purpose of the device and the techniques employed as

well as, if appropriate, a written report containing a critical evaluation of this

compilation;

1.1.2. or the results of all the clinical investigations made, including those

carried out in conformity with Section 2.

1.2. All the data must remain confidential, in accordance with the provisions

of Article 20.

A clinical investigation is a systematic investigation or study in or on one or

more human subjects, undertaken to verify the safety and/or performance of a

device.

Clinical investigator is an individual and/or institution responsible for the

conduct of a clinical investigation who and/or which takes the clinical

responsibility for the well-being of the subjects involved.

Ethics Committee is an independent and properly constituted

The objectives of clinical investigation are:

devices conform to essential requirement referred to in Annex I, and

use, and assess whether they constitute risks when weighed against

the intended performance of the device.

The rights, safety and wellbeing of clinical investigation subjects shall be

protected consistent with the ethical principles laid down in the ISO 14155

Assembly in Hong Kong in 1989. This shall be understood, observed and applied

at every step in the clinical investigation.

2.4.1. Clinical investigations must be performed on the basis of an

appropriate plan of investigation reflecting the latest scientific and technical

knowledge and defined in such a way as to confirm or refute the manufacturer's

claims for the device; these investigations must include an adequate number of

observations to guarantee the scientific validity of the conclusions.

2.4.2. The procedures used to perform the investigations must be

appropriate to the device under examination.

2.4.3. Clinical investigations must be performed in circumstances similar to

the normal conditions of use of the device.

2.4.4. All the appropriate features, including those involving the safety and

performances of the device, and its effect on patients must be examined.

2.4.5. All adverse incidents such as those specified in Article 10 must be

fully recorded and notified to the competent authority.

2.4.6. The investigations must be performed under the responsibility of a

medical practitioner or another authorized qualified person in an appropriate

environment.

The medical practitioner or other authorized person must have access to the

technical and clinical data regarding the device.

2.4.7. The written report, signed by the medical practitioner or other

authorized person responsible, must contain a critical evaluation of all the data

collected during the clinical investigation.

The notified body, its Director and the assessment and verification staff shall

not be the designer, manufacturer, supplier, installer or user of the devices which

they inspect, nor the authorized representative of any of these persons. They

may not be directly involved in the design, construction, marketing or

maintenance of the devices, nor represent the parties engaged in these activities.

This in no way precludes the possibility of exchanges of technical information

between the manufacturer and the body.

The notified body and its staff must carry out the assessment and

verification operations with the highest degree of professional integrity and the

requisite competence in the field of medical devices and must be free from all

pressures and inducements, particularly financial, which might influence their

judgment or the results of the inspection, especially from persons or groups of

persons with an interest in the results of the verifications. Should the notified

body subcontract specific tasks connected with the establishment and verification

of the facts, it must first ensure that the subcontractor meets the provisions of the

Schedule.

The notified body shall keep at the disposal of the CLAA the relevant

documents assessing the subcontractor's qualifications and the work carried out

by the subcontractor under this Schedule.

The notified body must be able to carry out all the tasks assigned to such

bodies by Schedules and for which it has been notified, whether these tasks are

carried out by the body itself or on its responsibility. In particular, it must have the

necessary staff and possess the facilities needed to perform properly the

technical and administrative tasks entailed in assessment and verification. This

presupposes the availability of sufficient scientific staff within the organization

who possess experience and knowledge sufficient to assess the medical

functionality and performance of devices for which it has been notified, having

regard to the requirements of this Schedule and, in particular, those set out in It

must also have access to the equipment necessary for the verifications required.

The notified body must have:

operations for which the body has been designated,

carry out and adequate experience of such inspections,

demonstrate that the inspections have been carried out.

The impartiality of the notified body must be guaranteed. Their remuneration

must not depend on the number of inspections carried out, nor on the results of

the inspections.

The body must take out civil liability insurance, unless liability is assumed by

the State under domestic legislation or the Member State itself carries out the

inspections directly.

The staff of the notified body is bound to observe professional secrecy with

competent administrative authorities of the State in which their activities are

carried out) pursuant to this Schedule or any provision of national law putting it

into effect.

ANNEX XII

1.1 Abnormal use: Act or omission of an act by the operator or user of a

medical device as a result of conduct that is beyond any reasonable means of

risk control by the manufacturer.

Note: Foreseeable misuse that is warned against in the instructions for

use is considered abnormal use if all other reasonable means of risk control

have been exhausted.

See Annex A for examples of potential abnormal use.

1.2 Immediate adverse event report: For purposes of adverse event

reporting, immediately means as soon as possible, but not later than 10

elapsed calendar days following the date of awareness of the event.

1.3 Intended purpose: the use for which the device is intended according to

the data supplied by the manufacturer on the labeling, in the instructions and/or in

promotional materials.

1.4 Malfunction or deterioration: a failure of a device to perform in

accordance with its intended purpose when used in accordance with the

manufacturer's instructions.

risk of death, serious injury, or serious illness that requires prompt remedial

action.

1.6 Unanticipated death or unanticipated serious injury: A death or

serious injury is considered unanticipated if the condition leading to the event

was not considered in a risk analysis performed during the design and

development phase of the device. There must be documented evidence in the

design file that such analysis was used to reduce the risk to an acceptable

level.

1.7 Use error: Act, or omission of an act, that has a different result to that

intended by the manufacturer or expected by the operator. Use error includes

slips, lapses, mistakes and reasonably foreseeable misuse. See Appendix D for

examples of potential use errors.

Any event which meets all of the three basic reporting criteria listed in

sections 2.1 through 2.3 below is considered as an adverse event and should be

reported to the CLAA.

It is possible that the manufacturer will not have enough information to

decide definitely on the reportability of an event. In such a case, the manufacturer

should make reasonable efforts to obtain additional information to decide upon

reportability. Where appropriate, the manufacturer should consult with the

medical practitioner or the health-care professional involved, and do his utmost to

retrieve the concerned device.

As a general principle, there should be a pre-disposition to report rather than

not to report in case of doubt on the reportability of an event.

The manufacturer becomes aware of information regarding an event which

has occurred with its device.

This may include information from device testing performed by the

manufacturer, user or other party.

Typical events are:

a) A malfunction or deterioration in the characteristics or performance.

b) An incorrect or out of specification test result

c) The discovery of a design flaw during design review

d) An inaccuracy in the labeling, instructions for use and/or promotional

materials. Inaccuracies include omissions and deficiencies.

Omissions do not include the absence of information that should generally

be known by the intended users.

e) The discovery of a serious public health threat.

This can include an event that is of significant and unexpected nature such

that it becomes alarming as a potential public health hazard

f) Use Error (for details see section 5)

g) Any other information that becomes available.

This can include information from the literature, other scientific

documentation or increase in trend (see appendix C).

In assessing the link between the device and the event, the manufacturer

should take into account:

- The opinion, based on available information, from a healthcare

professional;

- Information concerning previous, similar events;

- Complaint trends

- Other information held by the manufacturer.

This judgment may be difficult when there are multiple devices and drugs

involved. In complex situations, it should be assumed that the device was

associated with the event.

2.3.1 Death of a Patient, User or Other Person.

2.3.2 Serious Injury of a Patient, User or Other Person.

Serious injury (also known as serious deterioration in state of health) is

either:

-Life threatening illness or injury.

-Permanent impairment of a body function or permanent damage to a body

structure.

-A condition necessitating medical or surgical intervention to prevent

permanent impairment of a body function or permanent damage to a body

structure.

The interpretation of the term "serious” is not easy, and should be made in

consultation with a medical practitioner when appropriate.

The term “permanent” means irreversible impairment or damage to a body

structure or function, excluding minor impairment or damage.

Medical intervention is not in itself a serious injury. It is the reason that

motivated the medical intervention that should be used to assess the reportability

of an event.

2.3.3 No Death or Serious Injury Occurred but the Event Might Lead to

Death or Serious Injury of a Patient, User or Other Person if the Event Recurs.

Some jurisdictions refer to these events as near incidents.

All events do not lead to a death or serious injury. The non-occurrence of

such a result might have been due to circumstances or to the timely intervention

of health care personnel.

The event is considered “adverse” if in the case of reoccurrence, it could

lead to death or serious injury.

This applies also if the examination of the device or a deficiency in the

information supplied with the device, or any information associated with the

device, indicates some factor which could lead to an event involving death or

serious injury.

Include relevant information that might impact the understanding or

evaluation of the adverse event AND that is not included elsewhere in this report.

* Loss of sensing after a pacemaker has reached end of life. Elective

replacement indicator did not show up in due time, although it should have

according to device specification.

* On an X-ray vascular system during patient examination, the C arm had

uncontrolled motion. The patient was hit by the image intensifier and his nose

was broken. The system was installed, maintained, and used according to

manufacturer’s instructions.

* It was reported that a monitor suspension system fell from the ceiling

when the bolts holding the swivel joint broke off. Nobody was injured in the

surgical theater at that time but a report is necessary (near incident). The

system was installed, maintained, and used according to manufacturer’s

instructions.

on inner packaging. Outer package is removed but device is not used during

procedure. Device is stored with inner packaging only which does not offer a

sufficient sterile barrier.

* A batch of out-of-specification blood glucose test strips is released by

manufacturer. Patient uses strips according to instructions, but readings

provide incorrect values leading to incorrect insulin dosage, resulting in

hypoglycemic shock and hospitalization.

* Premature revision of an orthopedic implant due to loosening. No cause

yet determined.

* An infusion pump stops, due to a malfunction, but fails to give an alarm.

Patient receives under-infusion of needed fluids and requires extra days in

hospital to correct.

* Manufacturer of a pacemaker released on the market identified a

software bug. Initial risk assessment determined risk of serious injury as

remote. Subsequent failure results in new risk assessment by manufacturer

and the determination that the likelihood of occurrence of a serious injury is not

remote.

* Patients undergoing endometrial ablation of the uterus suffered burns to

adjacent organs. Burns of adjacent organs due to thin uterine walls were an

unanticipated side effect of ablation.

* Manufacturer does not change ablation device label and fails to warn of

this side effect which may be produced when the device is working within

specification.

* Healthcare professional reported that during implant of a heart valve, the

sewing cuff is discovered to be defective. The valve was abandoned and a new

valve was implanted and pumping time during surgery was extended.

* During the use of an external defibrillator on a patient, the defibrillator

failed to deliver the programmed level of energy due to malfunction. Patient

died.

* An intravenous set separates, the comatose patient’s blood leaks onto

the floor, the patient bleeds to death.

* Unprotected ECG cable plugged into the main electricity supply – patient

died.

* Fatigue testing performed on a commercialized heart valve bioprosthesis

demonstrates premature failure, which resulted in risk to public health.

* After delivery of an orthopedic implant, errors were discovered in heat

treatment records leading to non-conforming material properties, which resulted

in risk to public health.

* Testing of retained samples identified inadequate manufacturing

process, which may lead to detachment of tip electrode of a pacemaker lead,

which resulted in risk to public health.

* Manufacturer provides insufficient details on cleaning methods for

reusable surgical instruments used in brain surgery, despite obvious risk of

transmission of CJD.

(i) Subsequent to the approval of devices should be closely monitored once

they are marketed. The applicant shall furnish Periodic Safety Update Report in

order to:

a) Report all the relevant new information from all appropriate sources;

b) Relate these data to patient exposure;

c) Summarize the market authorization status in different countries and any

significant variation related to safety;

d) Indicate whether changes should be made to product information in

order to optimize the use of the product.

(ii) All relevant clinical and non-clinical safety data should cover only the

period of the report (interval data). The PSURs shall be submitted every six

months for the first two years after approval of the device is granted to the

applicant. For subsequent years- the PSURs need to be submitted annually.

PSURs due for a period must be submitted within 30 calendar days of the last

day of the reporting period. However, all cases involving serious unexpected

adverse reactions must be reported to the Licensing Authority within 30 days of

initial receipt of the information by the applicant. If marketing of the new device is

delayed by the applicant after obtaining approval to market, such data will have to

be provided on the deferred basis beginning from the time the new drug is

marketed.

(iii) New studies specifically planned or conducted to examine a safety issue

should be described in the PSURs.

(iv) A PSUR should be structured as follows:

product, applicant’s name, period covered by the report , date of approval

of new drug, date of marketing of new drug and date of reporting,

pharmacology and other related information.

Upon request by the manufacturer, and agreement by an CLAA, common

and well-documented events may be:

(a) Exempted from reporting or

(b) Changed to periodic or summary reporting.

As with all reported device complaints, all potential use error events and

potential abnormal use events should be evaluated by the manufacturer (see

Appendix D for examples). The evaluation is governed by risk management,

usability engineering, design validation, and corrective and preventive action

processes. Results should be available, upon request, to regulatory authorities

and conformity assessment bodies.

6.1.1 Use Error resulting in Death or Serious Injury/ Serious Public Health

Threat:

Use error related to medical devices, which did result in death or serious injury

or serious public health threat, should be reported by the manufacturer to the

national competent authority.

6.1.2 Use Error not resulting in Death or Serious Injury / Serious Public

Health Threat:

Use error related to medical devices, which did not result in death or serious

injury or serious public health threat, need not be reported by the manufacturer to

the national competent authority. Such events should be handled within the

manufacturer’s quality and risk management system, as described in Appendix D

Section 6.0. A decision to not report must be justified and documented.

6.1.3 Use Errors Becoming Reportable:

Use errors become reportable by the manufacturer to the national

competent authority when a manufacturer:

- notes a change in trend (usually an increase in frequency), or a change in

pattern of an issue that can potentially lead to death or serious injury or

public health concern.); or

- initiates corrective action to prevent death or serious injury or serious

public health threat.

Abnormal use need not be reported by the manufacturer to the CLA under

adverse event reporting procedures. Abnormal use should be handled by the

health care facility and appropriate regulatory authorities under specific

appropriate schemes not covered by this document (see Appendix D: Annex B).

If manufacturers become aware of instances of abnormal use, they may

bring this to the attention of other appropriate organizations and healthcare

facility personnel.

Adverse Events must be reported to a Central Licensing Authority (CLAA)

according to applicable requirements in each jurisdiction.

Upon becoming aware that an event has occurred and is associated with

one of its devices, the medical device manufacturer must determine whether it

is an adverse event.

Adverse events that result in unanticipated death or unanticipated serious

injury or represent a serious public health threat must be reported by the

manufacturer within 48 hours.

All other reportable events must be reported as soon as possible by the

manufacturer, but not later than 30-elapsed calendar days following the date of

awareness of the event.

If after becoming aware of a potentially reportable adverse event, there is

still uncertainty about whether the event is reportable, the manufacturer must

submit a report within the timeframe required for that type of event.

All report times refer to when the CLAA must first be notified. This

notification may be in the form of an initial report, final report or trend report as

defined in Appendix A Section B. The choice of report type depends on whether

all the applicable data specified in Appendix A is available within the appropriate

report time. If additional information is required, the manufacturer should provide

a follow-up or final report as soon as the information is available or as requested

by the CLAA.

Reports on Adverse events should include all available information in the

Universal Dataset for Adverse Event Reporting provided in Appendix A.

CLAA s may require certain adverse events to be reported as soon as

possible for public health reasons. In such cases, the report may not contain

complete information and should be followed up with a complete report.

The act of reporting an event to a CLAA is not to be construed as an

admission of manufacturer, user, or patient liability for the event and its

consequences. Submission of an adverse event report does not, in itself,

represent a conclusion by the manufacturer that the content of this report is

complete or confirmed, that the device(s) listed failed in any manner. It is also not

a conclusion that the device caused or contributed to the adverse event. It is

recommended that reports carry a disclaimer to this effect.

As far as it is practical and appropriate, the information needed to identify

and use the device safely should be provided on the device itself, and /or on the

packaging for each unit, and / or on the packaging of multiple devices. If

individual packaging of each unit is not practicable, the information should be set

out in the leaflet, packaging insert or other media supplied with, or applicable to,

one or multiple devices.

· Where the manufacturer supplies multiple devices to a single user and/or

location, it may be sufficient and appropriate to provide with them only a single

copy of the instructions for use. In these circumstances the device user should

have access to further copies upon request.

· The medium, format, content, readability and location of labeling should be

appropriate to the particular device, its intended purpose and the technical

knowledge, experience, education or training of the intended user(s). In particular,

instructions for use should be written in terms readily understood by the intended

user and, where appropriate, supplemented with drawings and diagrams. Some

devices may require separate information for the healthcare professional and the

lay user.

· Instructions may not be needed or may be abbreviated for devices of low

or moderate risk if they can be used safely and as intended by the manufacturer

without any such instructions.

· Labeling may be provided to the user in various media and by several

means such as printed documents, through a display screen incorporated into the

device, downloaded from the manufacturer’s Web Site using the Internet,

magnetic or optical media. Whatever the media or the means, information should

be targeted to the anticipated user population.

electronic labeling, e.g. paper versions must be available to users as well as

electronic ones.

· Any residual risk identified in the risk analysis should be reflected as

contraindications or warnings within the labeling.

· Country-specific requirements for labeling should be kept to the minimum

and, where they currently exist, eliminated as the opportunity arises.

· The use of internationally recognized (i.e. standardized) symbols should be

encouraged provided that device safety is not compromised by a lack of

understanding on the part of the patient or user. Where the meaning of the

symbol is not obvious to the device user, e.g. for a lay-user or for a newly

introduced symbol, an explanation should be provided.

Provided that safe and correct use of the device is ensured, a Regulatory

Authority may authorize labeling to be in one or more language(s) other than its

national language(s).

The labelling should bear the following particulars.

a) The name or trade name and address of the manufacturer and, if

appropriate, a phone

number and/or fax number and/or website address to obtain technical

assistance.

For imported devices, information may be required to contain in addition, the

name and address of either the importer established within the importing

country/region or of an authorized representative of the manufacturer established

within the importing country/region.

b) Sufficient details for the user to identify the device and, where these are

not obvious, its intended purpose, user and patient population of the device; also,

where relevant, the contents of any packaging.

c) An indication of either the batch code/lot number (e.g. on single-use

disposable devices or reagents) or the serial number (e.g. on electrically-powered

medical devices), where relevant, to allow appropriate actions to trace and recall

the devices.

d) An unambiguous indication of the date until when the device may be used

safely, expressed at least as the year and month (e.g. on devices supplied sterile,

single-use disposable devices or reagents), where this is relevant. Where

relevant, the storage conditions and shelf life following the first opening of the

primary container, together with the storage conditions and stability of working

solutions.

e) For devices other than those covered by (d) above, and as

appropriate to the type of device, an indication of the date of manufacture. This

indication may be included in the batch code/lot number or serial number.

f) The information needed to verify whether the device is properly installed

and can operate correctly and safely, plus details of the nature, and frequency of

preventative and regular maintenance, where relevant any quality control,

replacement of consumable components, and calibration needed to ensure that

g) Any warnings, precautions, limitations or contra-indications.

h) The performance intended by the manufacturer and, where relevant, any

undesirable side effects.

i) An indication on the external packaging of any special storage and /or

handling conditions that apply.

j) Details of any further treatment or handling needed before the device can

be used (e.g. sterilization, final assembly, calibration, preparation of reagents

and/or control materials, etc.) where relevant.

k) If the device is sterile, an indication of that condition and necessary

instructions in the event of damage to sterile packaging and, where appropriate,

description of methods of re-sterilization.

l) If the device has been specified by the manufacturer as intended for

single-use only, an indication of that state.

m) If the device is for use by a single individual and has been manufactured

according to a written prescription or pattern (i.e. it is custom-made), an indication

of that state.

diagnostic medical devices, performance evaluation, only, an indication of that

situation.

o) If the device is intended for presentation or demonstration purposes only,

an indication of that situation.

p) If the device is to be installed with or connected to other medical devices

or equipment, or with dedicated software, in order to operate as required for its

intended use, sufficient details of its characteristics to identify the correct devices

or equipment to use in order to obtain a safe combination.

q) If the device is implantable, information regarding any particular risks in

connection with its implantation.

r) Information regarding the risks of reciprocal interference posed by the

reasonably foreseeable presence of the device during specific investigations,

evaluations, treatment or use (e.g. electromagnetic interference from other

equipment).

s) If the device is reusable, information on the appropriate processes to

allow reuse, including cleaning, disinfection, packaging and, where appropriate,

the method of resterilization and any restriction on the number of reuses. Where

a device is supplied with the intention that it is sterilized before use, the

instructions for cleaning and sterilization should be such that, if correctly followed,

the device will still perform as intended by the manufacturer and comply with the

t) If the device is a reprocessed device, additionally the name of the

reprocessor, and identification of the device as a reprocessed device.

u) If the device emits radiation for medical purposes, details of the nature,

type and where appropriate, the intensity and distribution of this radiation.

v) Date of issue or latest revision of the instructions for use and, where

appropriate, an identification number.

The instructions for use should also include, where appropriate, details

informing the users and/or patient and allowing the medical staff to brief the

patient on any contra-indications, warnings and any precautions to be taken.

These details should cover in particular:

w) Precautions and/or measures to be taken in the event of changes in the

performance, or malfunction, of the device including a contact telephone number,

if appropriate.

x) Precautions and/or measures to be taken as regards exposure, in

reasonably foreseeable environmental conditions, to magnetic fields, external

electrical influences, electrostatic discharge, pressure or variations in pressure,

temperature, humidity, acceleration, thermal ignition sources, proximity to other

devices, etc.

y) If the device administers medicinal products, adequate information

regarding any medicinal product(s) which the device in question is designed to

administer, including any limitations in the choice of substances to be delivered.

Any medicinal substances or biological material incorporated into the device

as an integral part of the device.

aa) If the device has a measuring function, the degree of accuracy claimed

for it.

bb) Any requirement for special facilities, or special training, or particular

qualifications of the device user and/or third parties

cc) Any precautions to be taken related to the disposal of the device and/or

its accessories (e.g. lancets), to any consumables used with it (e.g. batteries or

reagents) or to any potentially infectious substances of human or animal origin.

dd) Where relevant, for devices intended for lay persons a statement clearly

directing the user not to make any decision of medical relevance without first

consulting his or her health care provider.

.

And for in vitro diagnostic medical devices, in addition to the information

required above, directions/instructions for the proper use of in vitro diagnostic

medical devices which may include:

ee) Intended use / purpose (e.g. monitoring, screening or diagnostic)

ff) Test principle.

gg) Specimen type.

hh) Conditions for collection, handling and preparation of the specimen.

ii) Reagent description and any limitation (e.g. use with a dedicated

instrument only).

jj) The metrological traceability of values assigned to calibrators and

trueness-control materials, including identification of applicable reference

materials and/or reference measurement procedures of higher order.

kk) Assay procedure including calculations and interpretation of results.

ll) Information on interfering substances that may affect the performance of

the assay.

mm) Analytical performance characteristics, such as sensitivity, specificity,

accuracy (which is a combination of trueness and precision).

nn) Diagnostic performance characteristics, such as sensitivity and

specificity.

oo) Reference intervals.

.