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S.I. No. 252/1994 -- European Communities (Medical Devices) Regulations, 1994.

S.I. No. 252/1994 -- European Communities (Medical Devices) Regulations, 1994. 1994 252

S.I. No. 252/1994:

EUROPEAN COMMUNITIES (MEDICAL DEVICES) REGULATIONS, 1994.

EUROPEAN COMMUNITIES (MEDICAL DEVICES) REGULATIONS, 1994.

The Minister for Health, in exercise of the powers conferred on him by Section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Directive 9¾2/EEC of 14th June 1993(1) concerning medical devices hereby makes the following Regulations:

(1) OJ No. L169 12.7.1993, p.1.

Citation and Commencement.

1. (1) These Regulations may be cited as the European Communities (Medical Devices) Regulations, 1994.

(2) ( a ) Article 17 of these Regulations shall come into effect generally on the 3rd day of August 1994.

( b ) These Regulations (other than article 17) shall come into operation on the 3rd day of August 1994 to give effect to article 17.

( c ) The provisions specified in paragraph (b) shall come into operation for all other purposes on the 1st day of January 1995.

2. (1) In these Regulations,

"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 the device to be used as intended by its manufacturer;

"authorised officer" means a person appointed under article 23 to be an authorised officer for the purposes of these Regulations;

"authorised representative" means an authorised representative established within the European Community;

"CE marking" means the EC mark of conformity consisting of the symbol 'CE'; a specimen form of which is set out in Schedule 12;

"custom-made" means, in relation to a device--

( a ) that it is manufactured specifically in accordance with a written prescription of a registered medical practitioner or a professional user which gives, under his responsibility, specific characteristics as to its design; and

( b ) that it is intended to be used only for a particular named patient;

but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the registered medical practitioner or professional user;

"device" means a medical device, that is to say an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which--

( a ) is intended by the manufacturer to be used for human beings for the purpose of--

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

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

(iii) investigation, replacement or modification of the anatomy or of a physiological process, or

(iv) control of conception; and

( b ) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means;

"the Directive" means Council Directive 9¾2/EEC on the approximation of the laws of Member States relating to medical devices(2);

(2)OJ No. L169 12.7.1993, p.1.

"essential requirements" means the requirements specified in schedule 1 and "relevant essential requirements" in relation to a device means such of those requirements, or such aspects of those requirements, as apply to it, but excluding, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;

"harmonised standard" means--

( a ) a technical specification adopted by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or both of them, upon a remit from the Commission of the European Community pursuant to Council Directive 83/189/EEC(3) laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Council Directive 88/182/EEC(4) and Council Directive 90/320/EEC(5), and the reference of which has been published in the Official Journal of the European Communities; or

(3) OJ No. L109 26.4.1983, p.8.

(4) OJ No. L 81 26.3.1988, p.75.

(5) OJ No. L128 18.5.1990, p.15.

( b ) a monograph of the European Pharmacopoeia on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the reference of which has been published in the Official Journal of the European Communities;

"intended for clinical investigation" means, in relation to a device, that it is intended for use by a registered medicinal practitioner or a professional user when conducting investigations of that device in an adequate human clinical environment;

"intended purpose" means, in relation to a device, the use for which it is intended according to the data supplied by the manufacturer on the labelling, and in any instructions and any promotional materials relating to it;

"manufacturer" means the person who is responsible 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;

"Member State" means a Member State of the European Union;

"the Minister" means the Minister for Health;

"notified body" means, in relation to any task, a body designated and notified in respect of that task in accordance with Article 16 of the Directive;

"placing on the market" means, in relation to a device, the first making available, whether in return for payment or free of charge, of a new or fully refurbished device other than a device intended for clinical investigation, with a view to distribution, use, or both, in the Community;

"putting into service" means, in relation to a device, making it ready for use in the State for the first time for its intended purpose;

"registered medical practitioner" has the meaning assigned by section of the Medical Practitioners Act 1978 ;

"relevant national standard" means, in relation to an essential requirement or an aspect of it--

( a ) a standard specification declared in accordance with Section 20 of the Industrial Research and Standards Act, 1961 (No. 20 of 1961), or

( b ) a standard declared or laid down by a body or person pursuant to the law of another Member State,

which conforms to a harmonised standard to which the Directive applies;

"relevant notified body identification number" means the identification number of the notified body which was responsible for carrying out tasks of the notified body under Schedule 2, 3, 4, 5, 6 or 7 as respects a procedure which has been followed by the manufacturer of a device, and, where there is more than one such notified body, means the identification number of each of them;

"used for in vitro diagnosis" means, in relation to a device, that it is a reagent, reagent product kit, instrument, equipment or system, whether used alone or in combination and that it is intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;

(2) A reference in these Regulations to an article or a Schedule which is not otherwise identified is to an article of, or a Schedule to, these Regulations.

(3) A reference in these Regulations to a paragraph or subarticle is to the paragraph or subarticle of the article in which the reference occurs.

(4) A reference in these Regulations to article of the Directive is to an Article of Council Directive 9¾2/EEC(6).

(6) OJ No. L169 12.7.1993, p.1.

(5) A word or an expression which is used in these Regulations and is also used in the Directive has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Directive.

Application.

3. (1) Subject to subarticle (4), these Regulations shall apply to medical devices and their accessories and, for the purposes of these Regulations, accessories shall be treated as devices in their own right.

(2) Where a device is intended to administer a medicinal product within the meaning of Article 1 of Council Directive 65/65/EEC(7), that device shall be governed by Directive 9¾2/EEC and these regulations, without prejudice to the provisions of Directive 65/65/EEC with regard to the medicinal product.

(7) OJ No. L22 9.6.1965, p.369.

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 be governed by Directive 65/65/EEC. The relevant essential requirements of Schedule 1 of these Regulations shall apply as far as safety and performance related device features are concerned.

(3) 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 Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorised in accordance with Directive 9¾2/EEC and these Regulations.

(4) These Regulations shall not apply to--

( a ) devices used for in vitro diagnosis;

( b ) active implantable devices covered by Directive 90/385/EEC(8);

(8) OJ No. L189 20.7.1990, p.17.

( c ) medicinal products covered by Directive 65/65/EEC(9);

(9) OJ No. 22 9.6.1965, p.269.

( d ) cosmetic products covered by Directive 76/768/EEC(10);

(10) OJ No. L262 27.9.1976, p.169.

( e ) human blood, human blood products, human plasma or blood cells of human origin or devices which, incorporate at the time of placing on the market, such blood products, plasma or cells;

( f ) transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin;

( g ) transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable, or non-viable products derived from animal tissue; or

( h ) products whose principal intended purpose is such that they fall under Directive 89/686/EEC(11) on personal protective equipment.

(11) OJ No. L399 30.12.1989, p.13.

(5) The Directive is a specific Directive within the meaning of Article 2 (2) of Directive 89/336/EEC(12).

(12) OJ No. L139 23.5.1989, p.19.

Classification of Devices.

4. (1) For the purposes of these Regulations, devices are classified into Classes I, IIa, IIb and III in accordance with the definitions, implementing rules and classification rules set out in Schedule 9.

(2) In the event of a dispute between the manufacturer and a notified body resulting from the application of the definitions and rules referred to in subarticle (1), the matter shall be referred to the Minister for decision.

(3) Where the Minister considers that--

( a ) application of the classification rules set out in Schedule 9 requires a decision with regard to the classification of a given device or category of devices; or

( b ) a given device should be classified, by way of derogation from the provisions of Schedule 9, in another class; or

( c ) the conformity of a device should be established, by way of derogation from the provisions of article 7, 8, 9 or 10, by applying solely one of the given procedures chosen from among those referred to in that article,

the Minister shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.

Essential requirements for devices.

5. (1) All devices placed on the market or put into service must comply with the relevant essential requirements.

(2) In determining which are the relevant essential requirements for a device and whether or not the device complies with any of the relevant essential requirements account shall be taken of its intended purpose.

(3) Where conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Schedule 10.

(4) In the case of a device which has been put into service, the essential requirements specified in Sections 8.7, 11.4 and 13 of Schedule 1 are complied with only if the information and particulars referred to in those Sections are in English (whether or not they are also in another language and whether or not the device is for professional or other use).

(5) A device shall be treated as complying with an essential requirement if it conforms and respects that requirement to a relevant national standard, unless there are reasonable indications that the device does not comply with that requirement.

(6) A device which is neither custom-made nor intended for clinical investigation and which bears the CE marking shall be taken to comply with the relevant essential requirements unless there are reasonable indications that the device does not comply with those requirements.

(7) A custom-made device in respect of which the conditions specified in Schedule 8 are satisfied, and in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Schedule 8, shall be taken to comply with the relevant essential requirements unless there are reasonable indications that the device does not comply with those requirements.

(8) A device intended for clinical investigation in respect of which--

( a ) notice has been given under article 16 (1) or article 16 (2);

( b ) the conditions specified in Schedule 8 are satisfied;

and

( c ) either--

(i) no notice has been given under article 16 (3) within the period of 60 days there referred; or

(ii) notice has been given under article 16 (4); or

(iii) authorisation for commencement has been given under article 16 (1),

shall be taken to comply with the relevant essential requirements unless there are reasonable indications that the device does not comply with those requirements.

CE marking.

6. (1) Except as provided by paragraph (2), every device placed on the market shall bear the CE marking (affixed following a procedure mentioned in article 7, 8, 9, 10 or 11, whether carried out in the State or elsewhere) in a visible, legible and indelible form--

( a ) on the device or its sterile pack, where practicable and appropriate;

( b ) the instructions for use; and

( c ) any sales packaging,

and the marking shall in each case be accompanied by the identification number of the relevant notified body for that device.

(2) Subarticle (1) shall not apply to--

( a ) a device which is custom-made or intended for clinical investigation; or

( b ) systems and procedure packs solely made up of devices bearing the CE marking.

(3) No device placed on the market shall bear a mark or inscription which is likely to mislead third parties with regard to the meaning or the graphics of the CE marking.

(4) Any other mark may be affixed to a device, its packaging or accompanying instruction leaflet, provided that the visibility and legibility of the CE marking is not thereby reduced.

(5) Where a device comes within the scope of a directive other than the Directive and that directive provides for the affixing of the CE marking, the CE marking shall not be affixed unless the relevant requirements of that other directive are also satisfied.

(6) Where a directive other than the Directive permits a manufacturer to choose which arrangements to apply during a transitional period, the CE marking shall indicate that the device fulfils only the provisions of those directives applied by the manufacturer.

(7) In a case falling within subarticle (6), particulars of the directives applied by the manufacturer, as published in the Official Journal of the European Communities, shall be given in the documents, notices or instructions required by the directives and accompanying the device.

Procedure for Affixing CE marking for Class I devices.

7. A device falling within Class I may bear the CE marking only if its manufacturer follows the EC declaration of conformity procedure set out in Schedule 7.

Procedure for affixing CE marking for Class IIa devices.

8. A device falling within Class IIa may bear the CE marking only if its manufacturer--

( a ) follows the EC declaration of conformity procedure set out in Schedule 7, together with--

(i) the EC verification procedure set out in Schedule 4; or

(ii) the EC declaration of conformity procedure (production quality assurance) set out in Schedule 5; or

(iii) the EC declaration of conformity procedure (product quality assurance) set out in Schedule 6, or

( b ) follows the EC declaration of conformity procedure (full quality assurance system) as set out in Schedule 2, excluding Section 4.

Procedure for affixing CE marking for Class IIb devices.

9. A device falling within Class IIb may bear the CE marking only if its manufacturer--

( a ) follows the EC declaration of conformity procedure (full quality assurance system) set out in Schedule 2, excluding Section 4; or

( b ) follows the EC-type examination procedure set out in Schedule 3, together with--

(i) the EC verification procedure set out in Schedule 4; or

(ii) the EC declaration of conformity procedure (production quality assurance) set out in Schedule 5; or

(iii) the EC declaration of conformity procedure (product quality assurance) set out in Schedule 6.

Procedure for affixing CE marking for Class III devices.

10. A device falling within Class III may bear the CE marking only if its manufacturer--

( a ) follows the EC declaration of conformity procedure (full quality assurance system) set out in Schedule 2; or

( b ) follows the EC-type examination procedure set out in Schedule 3, together with--

(i) the EC verification procedure set out in Schedule 4; or

(ii) the EC declaration of conformity procedure (production quality assurance) set out in Schedule 5.

Procedure for systems and procedure packs.

11. (1) Any person who puts together devices bearing the CE marking (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 that--

( a ) he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and he has carried out his operations in accordance with these instructions;

( b ) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and

( c ) his operations are subjected to appropriate methods of internal control and inspection.

(2) A system or procedure pack shall be treated as a device in its own right and shall be subjected to the relevant procedure under Article 7, 8, 9 or 10 where--

( a ) it incorporates any device which does not bear a CE marking; or

( b ) the chosen combination of devices is intended to be put to a different use to any intended by the manufacturer of each device.

(3) Any person who sterilises, for the purposes of placing on the market a system or procedure pack referred to in subarticle (2) or a CE marked medical device designed by its manufacturer to be sterilised before use, shall--

( a ) for the purposes of obtaining sterility follow one of the procedures referred to in Schedule 4, Schedule 5 or Schedule 6 which relates to the obtaining of sterility; and

( b ) make a written declaration that sterilisation has been carried out in accordance with the manufacturer's instructions.

(4) A conformity assessment procedure carried out by a notified body in relation to a system or procedure pack or device referred to in subarticle (3) shall be limited to the procedures referred to in paragraph (a) of that subarticle.

(5) A system or procedure pack solely made up of devices bearing the CE marking--

( a ) shall not bear an additional CE marking; and

( b ) shall be accompanied by the information referred to in Section 13 of Schedule 1 which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

(6) The declaration referred to in subarticles (1) and (3) (b) shall be kept available for the Minister or an authorised officer for a period of five years.

General Provisions relating to conformity assessment procedures.

12. (1) A notified body which is responsible for carrying out a conformity assessment procedure in connection with a device under article 7, 8, 9 or 10 shall, in doing so, take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out under the laws or administrative provisions in force before the 1st day of January 1995.

(2) Any manufacturer of a device or any notified body following a conformity assessment procedure for affixing the CE marking to a device shall take account of the results of any assessment or verification operations which have been carried out in accordance with the Directive or these Regulations at an intermediate stage of manufacture of the device.

(3) Any procedure set out in Schedule 3, 4, 7 or 8 which, by virtue of these Regulations, is to be followed by a manufacturer who has no place of business in the Community may be initiated there by his authorised representative.

(4) Where a conformity assessment procedure involves the intervention of a notified body, the manufacturer or his authorised representative may apply to any notified body which has been designated in accordance with Article 16 of the Directive to carry out tasks in respect of that type of conformity assessment procedure.

(5) Where a manufacturer has supplied information or data to a notified body in the course of a conformity assessment procedure, the notified body may require the manufacturer to provide any additional information or data which the notified body considers necessary for the purposes of that procedure.

(6) A decision made by a notified body in accordance with Schedule 2 or Schedule 3 shall--

( a ) specify the period of validity of the decision; and

( b ) be valid for an initial period of not more than 5 years.

(7) Where an agreement under which a notified body agrees to carry out a conformity assessment procedure for a manufacturer allows the manufacturer to apply to the notified body at a specified time for an extension of the period of validity of a decision mentioned in subarticle (6), the notified body may extend the period of validity for a period of 5 years.

(8) Where a period of validity has been extended under subarticle (7), the notified body may, on an application made by the manufacturer, grant a further extension of 5 years.

(9) The documentation relating to any of the procedures referred to in this article carried out in the State shall be in English or, subject to article 5 (4), in some other language acceptable to the notified body concerned.

(10) Notwithstanding non-compliance with article 7, 8, 9, 10 or 15 in relation to an individual device, the Minister may nevertheless authorise the placing on the market or putting into service of that device if he is satisfied that this would be in the interest of protection of health.

(11) A manufacturer shall, in following a conformity assessment procedure, observe the manufacturer's obligations set out in the Schedule on the procedure in question.

Obligations of persons other than manufacturers.

13. (1) Subject to subarticle (2), any obligation of a manufacturer under these Regulations shall extend to a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.

(2) Subarticle (1) shall not apply to a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.

Registration of persons placing devices on the market.

14. (1) A manufacturer in the State who, under his own name, places a device on the market in accordance with the procedures referred to in article 7 or article 15 shall--

( a ) inform the Minister of his registered address; and

( b ) supply the Minister with a description of the device which is sufficient to identify it.

(2) A person engaged in the activities referred to in article 11 within the State shall--

( a ) inform the Minister of his place of business; and

( b ) supply the Minister with descriptions of the devices to which article 11 applies which are sufficient to identify them.

(3) A person in the State who has been designated by a manufacturer who does not have a registered place of business in the Community to place on the market a device referred to in subarticle (1) shall inform the Minister of

( a ) his registered place of business; and

( b ) the type of device.

Custom-made devices.

15. (1) The manufacturer of a custom-made device shall--

( a ) follow the procedure set out in Schedule 8 (as it applies to custom-made devices) before that device is placed on the market; and

( b ) take all necessary measures to ensure that the manufacturing process ensures that each device manufactured to that process conforms to the documentation referred to in Section 3.1 of Schedule 8.

(2) The manufacturer may be required to submit to the Minister a list of custom-made devices which have been put into service in the State.

Clinical investigations.

16. (1) Before devices in Class I which are intended for clinical investigation are made available to a registered medical practitioner or authorised qualified person for the purposes of a clinical investigation to take place within the State, the manufacturer or his authorised representative shall follow the procedure referred to in Schedule 8 and notify the Minister. The Minister may authorise the commencement of the clinical investigation immediately after the date of notification provided that the ethics committee concerned has delivered a favourable opinion.

(2) In the case of devices falling within Class IIa, IIb or III which are intended for clinical investigation, the manufacturer or his authorised representative may not make the devices available unless he has given at least 60 days' prior notice in writing to the Minister of the making available of the devices for the intended investigation, in the form of the statement required by Schedule 8.

(3) If, within 60 days of the giving of the notice under subarticle (2), the Minister gives written notice to the manufacturer or authorised representative, that, on grounds relating to the health or safety of patients, users or others, devices should not be made available for the purposes of those investigations, devices may not be made available for those purposes pursuant to that notice under subarticle (2).

(4) Where the relevant ethics committee has issued a favourable opinion on a programme of clinical investigation, the Minister may give written notice to the manufacturer or his authorised representative within 60 days of the giving of notice under subarticle (2) that devices may be made available for the purposes of those investigations at any time after the giving of notice under this subarticle.

(5) The manufacturer of a device intended for clinical investigation shall--

( a ) take all necessary measures to ensure that the manufacturing process ensures that a device manufactured according to that process conforms to the documentation referred to in Section 3.2 of Schedule 8; and

( b ) authorise the assessment, or audit where necessary, of the effectiveness of the measures which he takes pursuant to this article.

(6) The manufacturer or his authorised representative shall--

( a ) keep available for the Minister or an authorised officer the report referred to in Section 2.3.7 of Schedule 10; and

( b ) keep the information contained in the statement referred to in subarticles (1) and (2) for a minimum period of 5 years.

(7) Clinical investigations shall be conducted in accordance with the provisions of Schedule 10.

(8) Subarticles (1), (2), (3) and (4) do not apply where clinical investigations are conducted using devices which are authorised in accordance with article 7, 8, 9 or 10 to bear the CE marking unless the aim of those investigations is to determine whether the device in question may be used for a purpose other than that referred to in the relevant conformity assessment procedure.

Notified bodies.

17. (1) The Minister may designate for the purposes of Article 16 of the Directive any corporate or other body, which in his opinion meets the criteria specified in Schedule 11, as a body which is to carry out tasks as part of a procedure mentioned in article 7, 8, 9 or 10 and, if he so designates a body, he shall designate the tasks which it is to carry out.

(2) The Minister may withdraw the designation of a notified body or vary the tasks for which the notified body has been designated.

Fees.

18. (1) A notified body may charge a fee which shall be equal to the amount which the notified body estimates it will incur in, or in connection with, carrying out or causing to be carried out the functions referred to in these Regulations in respect of the application concerned.

(2) Where the costs incurred are greater than the estimated fee, the difference between those costs and that fee shall be payable by the manufacturer or his authorised representative to the notified body, and where those costs are less than the estimated fee, the difference between those costs and that fee shall be repayable by the notified body to the manufacturer or his authorised representative, as the case may be.

Prohibition on placing on the market or putting into service.

19. (1) Subject to subarticle (6), a manufacturer shall not place on the market or put into service a device which does not comply with the relevant essential requirements.

(2) Subject to subarticles (3) and (6) a manufacturer shall not place on the market or put into service a device--

( a ) which does not bear the CE marking as required by article 6 (1); or

( b ) which bears a mark in contravention of article 6 (3).

(3) Subarticle (2) (a) does not apply to a device which is custom-made or intended for clinical investigation.

(4) The placing on the market or putting into service of a custom-made device in respect of which the manufacturer has contravened article 15 is prohibited.

(5) The making available to a registered medical practitioner of a device intended for clinical investigation in contravention of articles 16 (1) or 16 (2) or a notice under article 16 (3), is prohibited.

(6) Nothing in subarticles (1) or (2) shall prevent the showing at a trade fair, exhibition, demonstration or similar event of a device which does not comply with the relevant essential requirements or which does not bear the CE marking provided that a notice is prominently displayed at the event, so as to be readily visible to a prospective purchaser, indicating that the device--

( a ) does not comply with those requirements or does not bear that mark; and

( b ) may not be placed on the market or put into service until it complies with the requirements of the Directive.

Notification of Decisions.

20. (1) On taking a decision under these Regulations which results in the refusal or restriction on the placing on the market or the putting into service, by a person, of a device, the Minister or the notified body which took the decision shall as soon as practicable thereafter, send to the manufacturer or his authorised representative (as the case may be) a notice in writing of the decision stating the exact grounds on which it was based and informing the manufacturer or his authorised representative of his right to apply for a review of the decision under Article 21 and of the time limit for making such an application.

(2) Where a device, in respect of which a decision has been taken, has already been granted a CE marking approval in another Member State, the Minister shall so inform that other Member State and the Commission of the European Communities giving the reasons for the decision.

(3) The Minister, or an authorised officer under article 23, and notified bodies in other Member States may obtain from the notified body on request all relevant information submitted concerning the application for CE marking approval of the device and reports of the notified body arising from the application.

Review.

21. (1) Any person aggrieved by a decision of a notified body--

( a ) to refuse to grant a CE marking approval,

( b ) to suspend or withdraw a CE marking approval may apply to the Minister for a review of the decision.

(2) On reviewing a decision of a notified body under these Regulations, the Minister--

( a ) shall have the same powers and duties as the notified body has under these Regulations;

( b ) may hold an inquiry in connection with the review; and

( c ) may appoint an assessor.

(3) An application for a review shall state the grounds on which the application is made and shall be accompanied by the following documents: a copy of the application for a CE marking approval together with every other document submitted to the notified body in connection with that application and a copy of the notice from a notified body referred to in article 20 (1).

Information to be kept available for inspection.

22. A manufacturer who has submitted an application for CE marking under the conformity assessment procedures set out in the Schedules to these Regulations shall keep available for inspection any documentation required under the relevant Schedule or Schedules.

Authorised Officers.

23. (1) The Minister may appoint such and so many persons as the Minister deems fit to be authorised officers for the purpose of these Regulations.

(2) An authorised officer shall be furnished with a warrant of appointment as an authorised officer and, when exercising any power conferred on an authorised officer by these Regulations, shall, if requested by any person affected, produce the warrant to that person.

(3) An authorised officer--

( a ) shall obtain access, on request, to the place of manufacture or storage of devices and to the information referred to in article 22; and

( b ) shall obtain access on request to any ship or other vessel, aircraft, railway wagon or other vehicle in which he has reasonable grounds for believing that devices are being transported for sale in the State or export to Member State,

and there or at any place make such examinations, tests, or inspections as he may consider appropriate for the purposes of these Regulations.

(4) An authorised officer--

( a ) may ask the manufacturer of a device, his authorised representative or the person who places the device on the market or puts it into service, to supply the information provided for in article 22 (1) within a period specified by the authorised officer,

( b ) may select a sample of the device and take it away for examination and testing, and

( c ) shall take reasonable measures to guarantee confidentiality with regard to the forwarding of the copies relating to the EC type-examination.

(5) An authorised officer may require, where the information required to be kept available under article 22 is not available, that the manufacturer or his authorised representative have a test performed at his own expense within the time specified by an approved body to verify compliance with the standard specification applicable to it and the essential safety requirements.

Entry on Premises.

24. (1) If a Judge of the District Court is satisfied on the sworn information of an authorised officer that there are reasonable grounds for suspecting that an offence under these Regulations has been or is being committed on any premises or other place, he may issue a warrant under his hand authorising a specified authorised officer, accompanied by such member or members of the Garda Síochana as that officer thinks necessary, at any time or times within one month from the date of the issue of the warrant, to enter, if need be by force, and search the premises or other place specified in the warrant and--

( a ) to seize any device found there which in his opinion could not, without contravening article 5, be placed on the market, and

( b ) to require any person found there to give him his name and address and any other information in his possession in relation to any device referred to in paragraph (a).

(2) An application under subarticle (1) for an issue of a warrant shall be made to a Judge of the District Court district in which the premises or place to which the application relates is situated.

Service of notices.

25. (1) Where a notice, document or a model of a device is required by these Regulations to be sent or given to a person--

( a ) in the case of a person other than the Minister or a notified body, it shall be addressed to him and may be sent or given to him in some of the following ways:

(i) by delivering it to him,

(ii) by leaving it at the address at which he carries on business or ordinarily resides or, in a case in which an address has been furnished under article 14 (1) (a), at that address,

(iii) by sending it by prepaid registered post in a letter or package addressed to him at the address at which he carries on business or ordinarily resides or, in a case in which an address has been furnished under article 14 (1) (a), at that address.

( b ) in the case of the Minister or a notified body, paragraph (a) should apply subject to the deletion of "or ordinarily resides".

(2) For the purposes of subarticle (1) (a) a company within the meaning of the Companies Act, 1963 , shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or any other place at which it carries on business.

Offences.

26. (1) It shall be an offence to--

( a ) interfere with an authorised officer in the exercise of his duties under article 23;

( b ) refuse to comply with a request of an authorised officer under article 23;

( c ) disclose or use for business or commercial purposes or any other purpose any information relating to a CE marking approval application in the possession of a notified body without the consent of that body;

( d ) fail to take reasonable measures to guarantee confidentiality with regard to forwarding any documents under article 20 (3);

( e ) obstruct or interfere with an authorised officer or member of the Garda Síochána in the exercise of his powers under article 24 (1) or to refuse to give information required thereby;

( f ) contravene in any way any provisions or requirement of, or under article 5, 6, 19 or 22.

(2) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of a director, manager, secretary or other officer of the body corporate, the director, manager, secretary or other officer or any person purporting to act in such capacity shall also be guilty of an offence.

(3) Subject to the provisions of this article, in criminal proceedings against any person for contravening article 5 it shall be a defence for the person (other than the person established within the Community who first places a device on the market or puts it into service within the Community) to show that he took all reasonable steps and exercised all due diligence to avoid contravening the article.

(4) A person guilty of an offence under these Regulations shall be liable, on summary conviction, to imprisonment for a period not exceeding six months or to a fine not exceeding £1,000 or to both such imprisonment and fine.

(5) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act 1851, proceedings for an offence under these Regulations may be instituted at any time within one year from the date on which the offence was committed.

(6) An offence under these Regulations may be prosecuted by the Minister.

Transitional provisions.

27. Nothing in article 19 (1) or (4) shall prohibit the placing on the market or putting into service before the 14th day of June 1998 of a device, if the supply of the device was permitted within the State on the 31st day of December 1994.

SCHEDULE I.

(Corresponding to Annex 1 of the Directive).

ESSENTIAL REQUIREMENTS.

I. General Requirements.

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) of the Directive, 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.

II. Requirements Regarding Design and Construction.

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 as defined in Article 1 of Directive 65/65/EEC 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 specified in Directive 75/318/EEC.

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 tisues.

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 Council Directive 80/181/EEC(13).

(13) OJ No. L39, 15.2.1980, p.40. Directive as last amended by Directive 89/617/EEC (OJ No. L357 7.12.1989, p.28).

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 supplied 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 I or IIa 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:

( a ) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2) of the Directive or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, 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 custom-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 a 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 ) the performances referred to in section 3 and 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 reussable, 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 registered medical practitioner 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, as in Section I (6), such data must be established in accordance with Schedule 10.

SCHEDULE II.

(Corresponding to Annex 2 of the Directive).

EC DECLARATION OF CONFORMITY.

(Full quality assurance system).

1. The manufacturer must ensure application of the quality system apparoved 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 Community 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 the Directive which apply to them.

The manufacturer must affix the CE marking in accordance with Article 17 of the Directive 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. 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 post-production 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 incidennts 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 the Directive 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 organisation 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 of the Directive 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 Schedule 1 and data on the tests conducted in this connection,

-- the clinical data referred to in Schedule 10,

-- 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 presume that quality systems which implement the relevant harmonized standards conform to these requirements.

The assessment team must include at least one number 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 the Directive, 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 the Directive, issue the application with an EC 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 Directive. 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 Schedule 1, Section 7.4, the notified body shall, in view of the aspects addressed in that paragraph, consult one of the competent bodies established by the Member States in accordance with Directive 65/65/EEC 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 EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. This additional approval must take the form of a supplement to the EC 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 is established in the Community, the obligation to keep available the technical documentation shall fall to the person responsible for placing the device on the Community market or the importer referred to in Schedule 1, Section 13.3 (a).

7. Application to devices in classes IIa and IIb.

In line with Article 11 (2) and (3) of the Directive, this Schedule may apply to products in Classes IIa and IIb. Section 4, however, does not apply.

SCHEDULE III.

(Corresponding to Annex 3 of the Directive).

EC TYPE-EXAMINATION.

1. EC 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 the Directive.

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 the Directive. 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 above-mentioned drawings and diagrams and the operation of the product,

-- a list of the standards referred to in Article 5 of the Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in that Article 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 Schedule 1 and data on the tests conducted in this connection,

-- the clinical data referred to in Schedule 10,

-- 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 of the Directive, as well as the items not designed on the basis of the relevant provisions of the above mentioned 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 the Directive if the standards referred to in Article 5 of the Directive 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 carried out.

5. If the type conforms to the provisions of the Directive, the notified body issues the applicant with an EC 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 Schedule I, Section 7.4, the notified body shall, in view of the aspects addressed in that paragraph, consult one of the competent bodies established by the Member States in accordance with Directive 65/65/EEC 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 EC type-examination 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 EC 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 EC 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 EC type-examination certificates and supplements issued, refused or withdrawn.

7.2. Other notified bodies may obtain a copy of the EC 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 EC 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 is established in the Community, the obligation to keep available the technical documentation shall fall to the person responsible for placing the device on the Community market or the importer referred to in Schedule 1, Section 13.3 (a).

SCHEDULE VI.

(Corresponding to Annex 4 of the Directive).

EC VERIFICATION.

1. EC verification is the procedure whereby the manufacturer or his authorized representative established in the Community 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 EC type-examination certificate and meet the requirements of the Directive 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 EC type-examination certificate and to the requirements of the directive 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, pre-established provisions to be implemented to ensure homogeneous production and, where appropriate, conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Directive which apply to them. The manufacturer must affix the CE marking in accordance with Article 17 of the Directive 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 Schedule 5, 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 post-production 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 requiremennts of the Directive 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 of the Directive or equivalent tests must be carried out in order to verify, where appropriate, the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive 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 of the Directive or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Directive 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 per cent, with a non-conformity percentage of between 3 per cent and 7 per cent. The sampling method will be established by the harmonized standards referred to in Article 5 of the Directive, 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 national authorities:

-- 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 Schedule 3.

8. Application to devices in Class IIa.

In line with Article 11 (2) of the Directive, this Schedule may apply to products in Class IIa, 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 IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Schedule 7 and meet the requirements of the Directive 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 IIa with the technical documentation referred to in Section 3 of Schedule 7.

SCHEDULE V.

(Corresponding to Annex 5 of the Directive).

EC DECLARATION OF CONFORMITY.

(Production Quality Assurance).

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 Community 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 the Directive which apply to them.

The manufacturer must affix the CE marking in accordance with Article 17 of the Directive 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 EC 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 post-production 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 EC 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 organisational 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 date 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 Schedule 3.

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 IIa.

In line with Article 11 (2) of the Directive, this Schedule may apply to products in Class IIa, 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 IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Schedule 7 and meet the requirements of the Directive which apply to them.

SCHEDULE 6.

(Corresponding to Annex 6 of the Directive).

EC DECLARATION OF CONFORMITY.

(product Quality Assurance).

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 Schedule 5, 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 EC type-examination certificate and meet the provisions of the Directive which apply to them.

The manufacturer affixes the CE marking in accordance with Article 17 of the Directive 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 CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Schedule.

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 EC 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 post-production 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 of the Directive or equivalent tests are carried out to ensure that the products conform to the type described in the EC type-examination certificate and fulfil the provisions of the Directive 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 above mentioned 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 Directive 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 of the Directive 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 Schedule 3.

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 IIa.

In line with Article 11 (2) of the Directive, this Schedule may apply to products in Class IIa, 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 IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Schedule 7 and meet the requirements of the Directive which apply to them.

SCHEDULE 7.

(Corresponding to Annex 7 of the Directive).

EC DECLARATION OF CONFORMITY.

1. The EC Declaration of conformity is the procedure whereby the manufacturer or his authorized representative established in the Community who 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 the Directive which apply to them.

2. The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorized representative established in the Community must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured.

Where neither the manufacturer nor his authorized representative are established in the Community, this obligation to keep the technical documentation available must fall to the person(s) who place(s) the product on the Community market.

3. The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. 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 of the Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in that Article 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 Schedule 10,

-- 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 I devices with a measuring function, the manufacturer must observe not only the provisions laid down in this Schedule but also one of the procedures referred to in Schedule 4, 5 or 6. Application of the above mentioned Schedules 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 Schedule is applicable.

6. Application to devices in Class IIa.

In line with Article 11 (2) of the Directive, this Schedule may apply to products in Class IIa, subject to the following derogation:

6.1. Where this Schedule is applied in conjunction with the procedure referred to in Schedule 4, 5 or 6, the declaration of conformity referred to in the above mentioned Schedules forms a single declaration. As regards the declaration based on this Schedule, the manufacturer must ensure and declare that the product design meets the provisions of the Directive which apply to it.

SCHEDULE 8.

(Corresponding to Annex 8 of the Directive).

STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES.

1. For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative established in the Community 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 registered medical practitioner or other authorised 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 Schedule 1 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 Schedule 10:

-- 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 registered 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 the Directive.

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 of the Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in that Article 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 Schedule should be kept for a period of time of at least five years.

SCHEDULE 9.

(Corresponding to Annex 9 of the Directive).

CLASSIFICATION CRITERIA.

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 the Directive 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.

1.7. Central circulatory system.

For the purposes of the Directive, 'central circulatory system' means the following vessels:

arteriae pulmonales, aorta ascendens, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales,

truncus brachicephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.

1.8. Central nervous system.

For the purposes of the Directive, 'central nervous system' means brain, meninges and spinal cord.

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 I, 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 IIa:

-- if they may be connected to an active medical device in Class IIa 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 I.

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 IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa.

1.4. Rule 4.

All non-invasive devices which come into contact with injured skin:

-- are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,

-- are in Class IIb 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 IIa 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 I if they are intended for transient use,

-- are in Class IIa 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 I,

-- are in Class IIb 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 IIa.

All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.

2.2. Rule 6.

All surgically invasive devices intended for transient use are in Class IIa 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 III,

-- reusable surgical instruments, in which case they are in Class I,

-- intended to supply energy in the form of ionizing radiation in which cases they are in Class IIb,

-- intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,

-- 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 IIb.

2.3. Rule 7.

All surgically invasive devices intended for short-term use are in Class IIa 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 III,

-- or specifically for use in direct contact with the central nervous system, in which case they are in Class III,

-- or to supply energy in the form of ionizing radiation in which case they are in Class IIb,

-- or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III,

-- 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 IIb.

2.4. Rule 8.

All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:

-- to be placed in the teeth, in which case they are in Class IIa,

-- 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 III,

-- to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,

-- 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 m Class III.

3. Additional Rules applicable to active devices.

3.1. Rule 9.

All active therapeutic devices intended to administer or exchange energy are in class iia 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 IIb.

All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.

3.2. Rule 10.

Active devices intended for diagnosis are in Class IIa:

-- 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 IIb.

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 IIb.

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 IIa, 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 IIb.

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, as defined in Article 1 of directive 65/65/EEC, 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 IIb, unless they are implantable or long term invasive devices, in which case they are in Class III.

4.3. Rule 15.

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.

All devices intended specially to be used for disinfecting medical devices are in Class IIa.

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 IIa.

4.5. Rule 17.

All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III 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 IIb.

SCHEDULE 10.

(Corresponding to Annex 10 of the Directive).

CLINICAL EVALUATION.

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 Schedule 1 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 III. 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 of the Directive.

2. Clinical investigations.

2.1. Objectives.

The objectives of clinical investigation are:

-- to verify that, under normal conditions of use, the performance of the devices conform to those referred to in Section 3 of Schedule 1, and

-- to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute risks when weighed against the intended performance of the device.

2.2. Ethical considerations.

Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the 41st World Medical Assembly in Hong Kong in 1989. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.

2.3. Methods.

2.3.1. 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.

2.3.2. The procedures used to perform the investigations must be appropriate to the device under examination.

2.3.3. Clinical investigations must be performed in circumstances similar to the normal conditions of use of the device.

2.3.4. All the appropriate features, including those involving the safety and performances of the device, and its effect on patients must be examined.

2.3.5. All adverse incidents such as those specified in Article 10 of the Directive must be fully recorded and notified to the competent authority.

2.3.6. The investigations must be performed under the responsibility of a registered medical practitioner or another authorized qualified person in an appropriate environment.

The registered medical practitioner or other authorized person must have access to the technical and clinical data regarding the device.

2.3.7. The written report, signed by the registered medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation.

SCHEDULE II

(Corresponding to Annex II of the Directive).

CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES.

1. 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.

2. 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 judgement 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 Directive and in particular, of this Schedule. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor's qualifications and the work carried out by the subcontractor under the Directive.

3. The notified body must be able to carry out of the tasks assigned to such bodies by one of Schedules 2 to 6 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. It must also have access to the equipment necessary for the verifications required.

4. The notified body must have:

-- sound vocational training covering all the assessment and verification operations for which the body has been designated,

-- satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,

-- the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5. 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.

6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the State itself carries out the inspections directly.

7. The staff of the notified body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-a-vis the competent administrative authorities of the State in which their activities are carried out) pursuant to the Directive or any provision of national law putting it into effect.

SCHEDULE 12.

(Corresponding to Annex 12 of the Directive).

CE MARKING OF CONFORMITY

The CE conformity marking shall consist of the initials "CE" taking the following form:

si210y94p0006.gif

-- if the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

-- the various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm. This minimum dimension may be waived for small-scale devices.

GIVEN under the Official Seal of the Minister for Health, this 3rd day of August, 1994.

BRENDAN HOWLIN,

Minister for Health.

EXPLANATORY NOTE.

The purpose of these Regulations is to give effect to Council Directive 9¾2/EEC of 14th June 1993 concerning medical devices (O.J No. L 169, 12.07.1993, p.1). The effect of these Regulations is:--

-- to lay down essential safety requirements which medical devices (hereinafter referred to as "devices") must satisfy;

-- to provide for the affixing of a CE marking to a device once its manufacturer has followed the conformity assessment procedures prescribed in these Regulations;

-- to prohibit the placing on the market or putting into service of a device, other than a device which is either custom-made or intended for clinical investigation, which does not bear the CE marking; and also prohibit the use of any mark which is likely to be confused with the CE marking,

and to set out all other associated matters arising from the provisions of the Directive.



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