S.I. No. 253/1994:

EUROPEAN COMMUNITIES (ACTIVE IMPLANTABLE MEDICAL DEVICES) REGULATIONS, 1994.

EUROPEAN COMMUNITIES (ACTIVE IMPLANTABLE 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 90/385/EEC of 20th July, 1990⁽¹⁾ as amended by Council Directives 9¾2/EEC of 14th June, 1993⁽²⁾ and 93/68/EEC of 22nd July, 1993⁽³⁾ on the approximation of the laws of the Member States relating to active implantable medical devices hereby makes the following Regulations:

⁽¹⁾ O.J. No. L189, 20.07.1990, p.17.

⁽²⁾ O.J. No. L169, 12.07.1993, p.1.

⁽³⁾ O.J. No. L220, 30.08.1993, p.1.

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

(2) These Regulations shall come into force on the making thereof.

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 17 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 No. 9;

"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 practitioner or professional user;

"device" means an active implantable medical device, that being an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software necessary for is proper functioning which--

(a) is intended to be used for human beings

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

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

(iii) in the control of conception;

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

(c) relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and

(d) is intended to be totally or partially introduced surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain in the body after the procedure;

"the Directive" means the Council Directive 90/385/EEC⁽¹⁾ on the approximation of the laws of Member States relating to active implantable medical devices;

⁽¹⁾ O.J. No. L189, 20.07.1990, p.17.

"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, not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of clinical investigation;

"harmonised standard" means 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⁽²⁾ which lays a procedure for the provision of information in the field of technical standards and regulations, as amended by Council Directive 88/182/EEC⁽³⁾, and Council Directive 90/320/EEC⁽⁴⁾, and the reference of which has been published in the Official Journal of the European Communities;

⁽²⁾ O.J. No. L109, 20.04.1983, p.8.

⁽³⁾ O.J. No. L81, 26.03.1988, p.75.

⁽⁴⁾ O.J. No. L128, 18.05.1990, p.15.

"intended for clinical investigation" means in relation to a device, that it is intended for use by a registered medical practitioner when conducting clinical investigations of that device;

"intended purpose" means the use for which the device is intended and for which it is designed, according to the data supplied by the manufacturer in the instructions relating to it;

"manufacturer" means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, irrespective of whether these operations are carried out by that person himself or by an authorised representative;

"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 by the Minister in respect of that task in accordance with Article 11 of the Directive;

"placing on the market" means the first making available in return for payment or free of charge of a device, other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished.

"put into service" means make available to registered medical practitioners for implantation;

"registered medical practitioner" has the meaning assigned by section 2 of the Medical Practitioners Act, 1978 ;

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

(a) a standard specfication 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 Schedules 2, 3, 4 and 5 of these Regulations, and, where there is more than one such notified body, means the identification number of each of them;

(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 to an Article of the Directive is to an Article of Directive 90/385/EEC⁽¹⁾.

⁽¹⁾ O.J. No. L189, 20.07.1990, 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.

3. (1) These Regulations shall apply to active implantable medical devices.

(2) Whre advice is intended to administer a substance defined as a medicinal product within the meaning of Council Directive 65/65/EEC⁽²⁾ as last amended by Council Directive 87/21/EEC⁽³⁾, that substance shall be subject to the system of marketing authorisation provided for in that Directive.

⁽²⁾ O.J. No. L22, 09.02.1965, p.369/65.

⁽³⁾ O.J. No. L15, 17.01.1987, p.36.

(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, that device must be evaluated and authorised in accordance with the provision of the Directive 90/385/EEC.

(4) The Directive constitutes a specific Directive within the meaning of Article 2 (2) of Council Directive 89/336/EEC⁽⁴⁾.

⁽⁴⁾ O.J. No. L139, 23.05.1989, p.19.

4. (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) Any determination that a device complies with any essential requirements specified in Sections 1 to 5 of Schedule 1, and any evaluation of side effects or undesirable effects for the purposes of determining whether or not a device complies with any of the essential requirements, shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred in Section 1 of Schedule 7; and any determination as to whether or not a device complies with any other essential requirements may be based on such data.

(4) In the case of a device which has been put into service, the essential requirements specified in Sections 12, 13, 14 and 15 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 as respects that requirement to a relevant national standard, unless there are reasonable indications that the device does not comply with such requirements.

(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 such requirements.

(7) A custom-made device in respect of which the conditions specified in Schedule 6 are satisfied and which is accompanied by the statement referred to in section 1 of Schedule 6 shall be taken to comply with the relevant essential requirements unless there are reasonable indications that the device does not comply with such requirements.

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

(a) notice has been given under article 10 (1);

(b) either--

(i) no notice has been given under article 10 (2) within the period of 60 days there referred to; or

(ii) notice has been given under article 10 (3); and

(c) the conditions specified in Schedule 6 are satisfied,

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

5. (1) Except as provided by subarticle (2), every device placed on the market or put into service shall bear the CE marking (affixed following a procedure mentioned in article 6 whether carried out in the State or elsewhere) in a visible legible and indelible form--

(a) on the sterile pack;

(b) on any sales packaging; and

(c) on the instruction leaflet,

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

(2) Subarticle (1) does not apply to a device which is custom-made or intended for clinical investigation, and such device shall not bear the CE marking.

(3) No device placed on the market or put into service shall bear (whether on its pack, sales packaging or instruction leaflet or elsewhere) a mark which is likely to be confused with 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 is subject to other directives which also provide for the affixing of a CE marking, this marking shall indicate that the device is presumed to conform to the provisions of the other directives.

(6) During a transitional period where one or more of these directives allows the manufacturer to choose which arrangements to apply, the CE marking shall indicate conformity to the provisions only of those directives applied by the manufacturer. In addition, particulars of the directives applied, as published in the Official Journal of the EC, must be given in any documents, notices or instructions accompanying such devices, and these shall be accessible without it being necessary to destroy the packaging which keeps the device sterile.

6. (1) A device may bear the CE marking only if its manufacturer--

(a) follows the EC declaration of conformity procedure; or

(b) follows the EC type-examination procedure, together with--

(i) the EC verification procedure, or

(ii) the EC declaration of conformity to type procedure.

(2) The EC declaration of conformity procedure is the procedure by which the manufacturer--

(a) applies an approved quality system for the design, manufacture and final inspection of devices, and is subject to surveillance to ensure that he duly fulfils his obligations arising from the approved quality system;

(b) ensures and declares that the devices satisfy the relevant provisions of the Directive and, in particular, the relevant essential requirements; and

(c) having applied the CE marking in accordance with article 5, draws up and keeps a written declaration of conformity with the relevant provisions of the Directive, covering one or more identified specimens of the devices,

and Schedule 2 shall have effect for the purposes of that procedure.

(3) The EC type-examination procedure is the procedure by which a notified body ascertains and certifies that a representative sample of the production of devices envisaged satisfies the relevant provisions of the Directive; and Schedule 3 shall have effect for the purposes of that procedure.

(4) The EC verification procedure is the procedure by which a notified body verifies and certifies that devices conform to the type described in an EC type-examination certificate and satisfy the relevant provisions of the Directive; and Schedule 4 shall have effect for the purposes of that procedure.

(5) The EC declaration of conformity to type procedure is the procedure by which the manufacturer--

(a) applies a quality system approved for the manufacture of devices and conducts a final inspection of the devices;

(b) is subject to surveillance;

(c) ensures and declares that the devices conform to the type described in an EC type-examination certificate and conform to the relevant provisions of the directive; and

(d) having applied the CE marking in accordance with article 5, draws up and keeps a written declaration of conformity with the relevant provisions of the Directive covering one or more identified speciments of the devices, and Schedule 5 shall have effect for the purposes of that procedure.

(6) Any part of the EC type-examination procedure or the EC verification procedure which is to be followed by a manufacturer who has no place of business in the State, may instead be followed by his authorised representative.

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

7. (1) 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 verifications operations which have been carried out in accordance with the Directive or these Regulations at an intermediate stage of manufacturing of the device.

(2) Where the 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 11 of the Directive to carry out tasks in respect of that type of conformity procedure.

(3) The notified body may require, where duly justified, any information or data which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.

(4) Decisions taken by the notified bodies following the procedures set out in Schedules 2 and 3 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years.

(5) Notwithstanding non-compliance with article 6 in relation to an individual device, the Minister may nevertheless authorise the placing on the market and putting into service of that device if he is satisfied that this would be in the interest of protection of health.

(6) Where the Minister considers that the conformity of a device or a family of devices should be established by way of derogation from the provisions of article 6 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. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 9¾2/EEC⁽¹⁾.

⁽¹⁾ O.J. No. L169, 12.07.1993, p.1.

8. (1) Subject to subarticle (2), the obligations of these Regulations to be met by manufactures also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.

(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.

(3) Where appropriate, the procedures provided for in Schedules 3 and 4 may be discharged by the manufacturer's authorised representative.

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

(a) satisfy the conditions specified in Schedule 6 (as it applies to custom-made devices) before that device is placed on the market or put into service; and

(b) take all the necessary measures to ensure that the manufacturing process ensures that the device manufactured to that process conforms to the documentation referred to in Section 3.1 of Schedule 6.

(2) The conditions specified in Section 1 of Schedule 6 may be satisfied by the manufacturer's authorised representative, instead of by the manufacturer.

10. (1) Before devices intended for clinical investigation are made available to a medical specialist for the purpose of a clinical investigation to take place within the State their manufacturer or his authorised representative shall give at least 60-days' notice in writing to the Minister of the making available of the devices for the intended investigation, in the form of the statement provided for by Sections 1 and 2.2 of Schedule 6 and the undertaking by the manufacturer mentioned in Section 3 of that Schedule.

(2) If, within 60 days of the giving of that notice, the Minister gives written notice to the manufacturer or his 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 (1).

(3) The Minister may, however, authorise a manufacturer to start the clinical investigations in question before the expiry of the 60 day period, provided that the ethics committee concerned has delivered a favourable opinion with respect to the investigation programme in question.

(4) The manufacturer of a device intended for clinical investigation shall 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 6 and may authorise the evaluation, by audit where necessary, of the effectiveness of the measures which he takes pursuant to Schedule 6.

(5) A manufacturer who has given the undertaking mentioned is subarticle (1) shall, if so required by the Minister for the purposes of his functions under subarticle (2), make available to him documentation which he has undertaken to keep available.

11. (1) The Minister may designate for the purposes of Article 11 of the Directive any corporate or other body, which in his opinion meet the criteria specified in Schedule 8 as a body which is to carry out tasks as part of a procedure mentioned in article 6 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.

12. (1) A notified body may chage 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.

13. (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 requirement.

(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 5 (1); or

(b) which bears a mark in contravention of article 5 (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 or his authorised representative has contravened article 9 is prohibited.

(5) The making available, in contravention of article 10 (1) or a notice under article 10 (2), of a device intended for clinical investigation is prohibited.

(6) Nothing in subarticles (1) or (2) prevents 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 requirements of the Directive.

14. (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 is 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 15 and of the time limit for making such an application.

(2) Where a device, in respect of which a decision to which subarticle (1) applies 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) In the event of a decision as referred to in subarticle (1) the manufacturer or his authorised representative shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.

(4) The Minister, or an authorised officer under article 17, and notified bodies in other Member States, may obtain from the notified body on request all relevant information submitted concerning the application for approval of the device and reports of the notified body arising from the application.

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

(a) to refuse to grant a CE marking approval; or

(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 under this article shall be made by written notice to the Minister which shall be lodged with him not later than 14 days from the date on which the notice of the decision in respect of which the application is made was given.

(4) A notice of review under these Regulations shall state the grounds on which the appeal is made and shall be accompanied by the following documents: a copy of the application for a CE mark 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 14 (1).

16. (1) 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.

17. (1) The Minister may appoint such and so many persons as the Minister deems fit to be authorised officers for the purposes 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 16;

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 a Member State,

and there or at any other 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 in the Community, to supply the information provided for in article 16 within a period specified by the authorised officer;

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

and

(c) shall take all reasonable measures to guarantee confidentiality with regard to the forwarding of copies of reports or documentation relating to the CE marking approval or application for approval of the device.

(5) An authorised officer may require, where the information required to be kept available under article 16 is not available, that the manufacturer or his authorised representative have a test and/or examination carried out at his own expense within the time specified by a notified body to verify compliance with the standard specification applicable to it and the essential safety requirements.

18. (1) Where 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 Síochána 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 4 be placed on the market;

and

(b) to require any person found there to give 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.

19. (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,

(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.

(b) where the person is the Minister, or a notified body, paragraph (a) shall apply subject to the deletion of "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.

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

(a) interfere with an authorised officer in the exercise of his duties under article 17;

(b) refuse to comply with a request of an authorised officer under article 17;

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

(d) fail to take reasonable measures to guarantee confidentiality with regard to forwarding of any documents under article 14 (4);

(e) obstruct or interfere with an authorised officer or a member of the Garda Síochána in the exercise of his powers under article 18 (1), or to refuse to give information required thereby, or

(f) contravene in any way any provisions or requirement of, or under, article 4, 5, 13, or 16.

(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 4 it shall be a defence for the person (other than the person established within the Community who first places a device on the market 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 convictions, 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.

21. (1) Nothing in article 13 (1), (2) or (4) shall prohibit the placing on the market or putting into service before 31st December 1994 of a device, if the supply of the device was permitted in the State on 31st December 1993.

SCHEDULE 1

(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 implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients. They must not present any risk to the persons implanting them or, where applicable, to other persons.

2. The devices must achieve the performances intended by the manufacturer, viz. be designed and manufactured 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 him.

3. The characteristics and performances referred to in sections 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.

4. The devices must be designed, manufactured and packed in such a way that their characteristics and performances are not adversely affected in the storage and transport conditions laid down by the manufacturer (temperature, humidity, etc.).

5. Any side effects or undesirable conditions must constitute acceptable risks when weighed against the performances intended.

II. Requirements regarding design and construction.

6. The solutions adopted by the manufacturer for the design and construction of the devices must comply with safety principles taking account of the generally acknowledged state of the art.

7. Implantable devices must be designed, manufactured and packed in a non-reusable pack according to appropriate procedures to ensure they are sterile when placed on the market and, in the storage and transport conditions stipulated by the manufacturer, remain so until the packaging is removed and they are implanted.

8. Devices must be designed and manufactured in such a way as to remove or minimize as far as possible:

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

-- risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,

-- risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration,

-- risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment,

-- risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in directive 80/836/Euratom⁽¹⁾, as amended by directives 84/467/Euratom⁽²⁾ and 84/466/Euratom⁽³⁾,

⁽¹⁾ O.J. No. L246, 17.09.1980, p.1.

⁽²⁾ O.J. No. L265, 5.10.1984, p.4.

⁽³⁾ O.J. No. L265, 5.10.1984, p.1.

-- risks which may arise where maintenance and calibration are impossible, including:

-- excessive increase of leakage currents,

-- ageing of the materials used,

-- excess heat generated by the device,

-- decreased accuracy of any measuring or control mechanism.

9. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in I. "General Requirements", with particular attention being paid to:

-- the choice of materials used, particularly as regards toxicity aspects,

-- mutual compatibility between the materials used and biological tissues, cells and body fluids, account being taken of the anticipated use of the device,

-- compatibility of the devices with the substances they are inteded to administer,

-- the quality of the connections, particularly in respect of safety,

-- the reliability of the source of energy,

-- if appropriate, that they are leakproof,

-- proper functioning of the programming and control systems including software.

10. Where a device incorporates, as an integral part, a substance which, when used separately, is likely to be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC, and whose action in combination with the device may result in its bioavailability, the safety, quality and usefulness of the substance, account being taken of the purpose of the device, must be verified by analogy with the appropriate methods specified in directive 75/318/EEC⁽¹⁾, as last amended by directive 89/341/EEC^(2).

⁽¹⁾O.J. No. L147, 9.06.1975, p.1.

⁽²⁾O.J. No. L142, 25.05.1989, p.11.

11. The devices and, if appropriate, their component parts must be identified to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices and their component parts.

12. Devices must bear a code by which they and their manufacturer can be unequivocably identified (particularly with regard to the type of device and year of manufacture); it must be possible to read this code, if necessary, without the need for a surgical operation.

13. When a device or its accessories bear instructions required for the operation of the device or indicate operating or adjustment parameters, by means of a visual system, such information must be understandable to the user and, as appropriate, the patient.

14. Every device must bear, legibily and indelibly, the following particulars, where appropriate in the form of generally recognized symbols:

14.1 On the sterile pack:

-- the method of sterilization,

-- an indication permitting this packaging to be recognised as such,

-- the name and address of the manufacturer,

-- a description of the device,

-- if the device is intended for clinical investigations, the words: "exclusively for clinical investigations",

-- if the device is custom-made, the words "custom-made device",

-- a declaration that the implantable device is in a sterile condition,

-- the month and year of manufacture,

-- an indication of the time limit for implanting in a device safely.

14.2 On the sales packaging:

-- the name and address of the manufacturer,

-- a description of the device,

-- the purpose of the device,

-- the relevant characteristics for its use,

-- if the device is intended for clinical investigations, the words: "exclusively for clinical investigations",

-- if the device is custom-made, the words: "custom-made device",

-- a declaration that the implantable device is in a sterile condition,

-- the month and year of manufacture,

-- an indication of the time limit for implanting a device safely,

-- the conditions for transporting and storing the device.

15. When placed on the market, each device must be accompanied by instructions for use giving the following particulars:

-- the year of authorization to affix the CE marking,

-- the details referred to in 14.1 and 14.2, with the exception of those referred to in the eight and ninth indents,

-- the performances referred to in section 2 and any undesirable side effects,

-- information allowing the registered medical practitioner to select a suitable device and the corresponding software and accessories,

-- information constituting the instructions for use allowing the registered medical practitioner and, where appropriate, the patient to use the device, its accessories and software correctly, as well as information on the nature, scope and times for operating controls and trials and, where appropriate, maintenance measures.

-- information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided,

-- information regarding the risks of reciprocal interference (1) in connection with the presence of the device during specific investigations or treatment,

-- the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate methods of resterilization,

-- an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsiblity of the manufacturer to comply with essential requirements.

The instruction leaflet must also include details allowing the registered medical practitioner to brief the patent on the contra-indications and the precautions to be taken. These details should cover in particular:

-- information, allowing the lifetime of the energy source to be established,

-- precautions to be taken should changes occur in the device's performance,

(1) "Risks of reciprocal interference" means advers effects on the device caused by instruments present at the time of investigations or treatment and vice versa.

-- 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, etc.,

-- adequate information regarding the medicinal products which the device in question is designed to administer.

16. Confirmation that the device satisfies the requirements in respect of characteristics and performances, as referred to in I. "General Requirements", in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Schedule 7.

SCHEDULE 2.

(Corresponding to Annex 2 of the Directive).

EC Declaration of Conformity (complete quality assurance system).

1. The manufacturer shall apply the quality system approved for the design, manufacture and final inspection of the products concerned as specified in sections 3 and 4 and shall be subject to EC surveillance as specified in section 5.

2. The declaration of conformity is the procedure by means of which the manufacturer who satisfies the obligations of section 1 ensures and declares that the products concerned meet the provisions of the Directive which apply to them.

The manufacturer or his authorised representative established within the Community shall affix the CE marking in accordance with Article 12 of the Directive and shall draw up a written declaration of conformity.

This declaration shall cover one or more identified specimens of the product and shall be kept by the manufacturer or his authorised representative established within the Community.

The CE marking shall be accompanied by the identification number of the notified body responsible.

3. Quality system:

3.1 The manufacturer shall make an application for evaluation of his quality system to a notified body.

The application shall include:

-- all the appropriate items of information for the category of products manufacture of which is envisaged,

-- the quality-system documentation,

-- an undertaking to fulfill the obligations arising from the quality system as approved,

-- an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,

-- an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system. The undertaking shall include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:

(i) any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health;

(ii) any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.

3.2 The 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 controls.

All the elements, requirements and provisions adopted the manufacturer for his quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records.

It shall include in particular an adequate description of:

(a) the manufacturer's quality objectives;

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

-- the organizational structures, the responsibilities of the managerial staff and their organizational authority where quality of design and manufacture of the products is concerned,

-- the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the design and of the products, including control of products which do not conform;

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

-- the design specifications, including the standards which will be applied and a description of the solutions adopted to fulfil the essential requirements which apply to the products when the standards referred to in Article 5 of the Directive are not applied in full,

-- the techniques of control and verification of the design, the processes and systematic actions which will be used when the products are being designed;

(d) the techniques of control and of quality assurance at the manufacturing stage and in particular:

-- the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,

-- 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 effected before, during and after production, the frequency with which they will take place, and the test equipment used.

3.3 Without prejudice to Article 13 of the Directive, the notified body shall effect an audit of the quality system to determine whether it meets the requirements referred to in 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards.

The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer's premises.

The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluations.

3.4 The manufacturer shall inform the notified body which has approved the quality system of any plan to alter the quality system.

The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation.

4. Examination of the design of the product.

4.1 In addition to the obligations incumbent on him under section 3, the manufacturer shall make 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 3.1.

4.2 The application shall describe the design, manufacture, and performances of the product in question and shall include the necessary particulars which make it possible to evaluate whether it complies with the requirements of the Directive.

It shall include inter alia:

-- the design specifications, including the standards which have been applied,

-- the necessary proof of their appropriations, in particular where the standards referred to in Article 5 of the Directive have not been applied in full. This proof must include the results of the appropriate tests carried out by the manufacturer or carried out under his responsibility,

-- a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of Schedule 1, whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted,

-- the clinical data referred to in Schedule 7,

-- the draft instruction leaflet.

4.3 The notified body shall examine the application and, where the product complies with the relevant provisions of the Directive, shall issue the applicant with an EC design examination certificate. The notified body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Directive may be evaluated. The certificate shall contain the conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.

4.4 The applicant shall inform the notified body which issued the EC design examination certificate of any modification made to the approved design. Modifications made to the approved design must obtain supplementary approval from the notified body which issued the EC design examination certificate where such modifications may affect conformity with the essential requirements of the Directive or the conditions prescribed for the use of the product. This supplementary approval shall be given in the form of an addendum to the EC design examination certificate.

5. Surveillance.

5.1 The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system.

5.2 The manufacturer shall authorise the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:

-- the quality-system documentation,

-- the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, etc.,

-- the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardisations/calibrations and the qualifications of the staff concerned, etc.

5.3 The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.

5.4 In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.

6. Administrative Provisions.

6.1 For at least five years from last date of manufacture of the product, the manufacturer shall keep available for the national authorities:

-- the declaration of conformity,

-- the documentation referred to in the second indent of section 3.1,

-- the amendments referred to in section 3.4,

-- the documentation referred to in section 4.2,

-- the decisions and reports of the notified body referred to in sections 3.4, 4.3, 5.3, and 5.4.

6.2 On request, the notified body shall make available to the other notified bodies and the competent authority all relevant information on approvals of quality systems issued, refused or withdrawn.

6.3 Where neither the manufacturer nor his authorised re-preventative are established in the Community, the task of keeping available for the authorities the technical documentation referred to in Article 4 (2) of the Directive shall fall to the person responsible for placing the appliance on the Community market.

SCHEDULE 3.

(Corresponding to Annex 3 of the Directive).

EC type-examination.

1. EC type-examination is the procedure whereby a notified body observes and certifies that a representative sample of the production envisaged satisfies the relevant provisions of the Directive.

2. The application for EC type-examination shall be made by the manufacturer, or by his authorized representative established in the community, to a notified body.

The application shall include:

-- the name and address of the manufacturer and the name and address of the authorized representative if the application is made by the latter.

-- a written declaration specifying that an application has not been made to any other notified body,

-- the documentation described in section 3 needed to allow an evaluation to be made of the conformity of a representative sample of the production in question, hereinafter referred to as "type", with the requirements of the directive. The applicant shall make a "type" available to the notified body. The notified body may request to the samples as necessary.

3. The documentation must make it possible to understand the design, the manufacture and the performance of the product. The documentation shall contain the following items in particular:

-- a general description of the type,

-- design drawings, methods of manufacture envisaged, in particular as regards sterilization, and diagrams of parts, sub-assemblies, circuits, etc.,

-- the descriptions and explanations necessary for the understanding of the above mentioned drawings and diagrams and of 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 a description of the solutions adopted to satisfy the essential requirements where the standards referred to in that Article have not been applied,

-- the results of design calculations, investigations and technical tests carried out, etc.,

-- a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of Schedule 1, whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted,

-- the clinical data referred to in Schedule 7,

-- the draft instruction leaflet.

4. The notified body shall:

4.1 examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in Article 5 of the Directive, as well as the items for which the design is not based on the relevant provisions of the said standards;

4.2 carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of the Directive where the standards referred to in Article 5 thereof have not been applied;

4.3 carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where 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. Where the type meets the provisions of the Directive, the notified body shall issue an EC type-examination certificate to the applicant. The Certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved.

The significant parts of the documentation shall be attached to the certificate and a copy shall be kept by the notified body.

6. The applicant shall inform the notified body which issued the EC type-examination certificate of any modification made to the approved product.

Modifications to the approved product must receive further approval from the notified body which issued the EC type-examination certificate where such modifications may affect conformity with the essential requirements or with the conditions of use specified for the product. This new approval shall be issued, where appropriate, in the form of a supplement to the initial EC type-examination certificate.

7. Administrative provisions

7.1 On request, each notified body shall make available to the other notified bodies and the competent authority, all relevant information on EC type-examination certificates and addenda issued, refused or withdrawn.

7.2 Other notified bodies may obtain a copy of the EC type-examination certificates and/or the addenda to them. The annexes to the certificates shall be made available to the other notified bodies when a reasoned application is made and after the manufacturer has been informed.

7.3 the manufacturer or his authorised representative shall keep with the technical documentation a copy of the EC type-examination certificates and the supplements to them for a period of at least five years from the manufacture of the last appliance.

7.4 Where neither the manufacturer nor the authorised representative are established in the Community, the task of keeping the technical documentation available for the authorities shall fall to the person responsible for placing the appliance concerned on the Community market.

SCHEDULE 4.

(Corresponding to Annex 4 of the Directive).

EC verification

1. EC verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the products subject to the provisions of section 3 are in conformity with the type as described in the EC type-examination certification and satisfy the requirements of the Directive that apply to them.

2. The manufacturer or his authorised representative established within the Community shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the EC type-examination certification and to the requirements of the Directive that apply to them. The manufacturer or his authorised representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity.

3. The manufacturer shall, before the start of the manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the EC type-examination certificate as well as with the relevant requirements of the Directive.

4. The manufacturer shall undertake to institute and keep updated a post-marketing surveillance system. This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the following events on learning of them:

(i) any change in the characteristics or the performances and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or deterioration in his state of health;

(ii) any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer.

5. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of the Directive by examination and testing of the products on a statistical basis, as specified in section 6. The manufacturer must authorise the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate.

6. Statistical verification

6.1 Manufacturers shall present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.

6.2 a random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standard(s) referred to in Article 5 of the Directive, or equivalent tests shall be carried out to verify their conformity to the type as described in the EC type-examination certificate and thereby determine whether a batch is to be accepted or rejected.

6.3 Statistical control of products shall be based on attributes, entailing a sampling system with the following characteristics:

-- a level of quality corresponding to probability of acceptance of 95 per cent., with a non-conformity percentage of between 0.29 and 1 per cent.,

-- a limit quality corresponding to a probability of acceptance of 5 per cent., with a percentage of non-conformity of between 3 and 7 per cent.

6.4 Where batches are accepted, the notified body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity.

Where, a batch is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the notified body may suspend the statistical verification.

The manufacturer may, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process.

6.5 The manufacturer or his authorised representative shall ensure that he is able to supply the notified body's certificates of conformity on request.

SCHEDULE 5.

(Corresponding to Annex 5 of the Directive).

EC declaration of conformity to type (assurance of production quality)

1. The manufacturer shall apply the quality system approved for the manufacture and shall conduct the final inspection of the products concerned as specified in 3; he shall be subject to surveillance referred to in section 4.

2. This declaration of conformity is the procedural element whereby the manufacturer sho satisfies the obligations of section 1 guarantees 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 or his authorised representative established within the Community shall affix the CE marking in accordance with Article 12 of the Directive and draw up a written declaration of conformity. This declaration shall cover one or more identified specimens of the product and shall be kept by a manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible.

3. Quality system

3.1 The manufacturer shall make an application for evaluation of his quality to a notified body. The application shall include:

-- all appropriate information concerning the products which it is intended to manufacture,

-- the quality-system documentation,

-- an undertaking to fulfil the obligations arising from the quality system as approved,

-- an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,

-- where appropriate, the technical documentation relating to the approved type and a copy of the EC type-examination certificate,

-- an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system. The undertaking shall include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:

(i) any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health;

(ii) any technical or medical reason resulting in withdrawal of a device from the market 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 shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records.

It shall include in particular an adequate description of:

(a) the manufacturer's quality objectives;

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

--the 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 the design and of the products, including control of products which do not conform;

(c) the techniques of control and of quality assurance at the manufacturing stage and in particular:

-- the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,

-- 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 which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used.

3.3 Without prejudice to Article 13 of the Directive, the notified body shall effect an audit of the quality system to determine whether it meets the requirements referred to in 3.2. It shall presume conformity with these requirements for the quality system which use the corresponding harmonized standards.

The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer's premises.

The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation.

3.4 The manufacturer shall inform the notified body which has approved the quality system of any plan to alter that system.

The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation.

4. Surveillance

4.1 The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system.

4.2 The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:

-- the quality-system documentation,

-- the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/calibrations and the qualifications of the staff concerned, etc.

4.3 The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.

4.4 In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.

5. The notified body shall communicate to the other notified bodies all relevant information concerning approvals of quality systems issued, refused or withdrawn.

SCHEDULE 6.

(Corresponding to Annex 6 of the Directive).

Statement concerning devices intended for special purposes.

1. The manufacturer or his authorized representative established within the Community shall draw up for custom-made devices or for devices intended for clinical investigations the statement comprising the elements stipulated in section 2.

2. The statement shall comprise the following Information:

2.1 For custom-made devices:

-- data allowing the device in question to be identified,

-- a statement affirming that the device is intended for exclusive use by a particular patient, together with his name,

-- the name of the registered medical practitioner who drew up the prescription and, if applicable, the name of the clinic concerned,

-- the particular features of the device as described by the medical prescription concerned,

-- a statement affirming that the device complies with the essential requirements given in Schedule 1 and, where applicable, indicating which essential requirements have not been wholly met, together with the grounds.

2.2 For devices intended for clinical investigations covered in Schedule 7:

-- data allowing the devices in question to be identified,

-- an investigation plan giving in particular the purpose, scope and number of the devices concerned,

-- the name of the registered medical practitioner and of the institution responsible for the investigations,

-- the place, date of commencement and duration scheduled for the investigations,

-- a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of 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 shall undertake to keep available for the competent national authorities:

3.1 For custom-made devices, documentation enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirement of the Directive to be assessed.

The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation referred to in the first paragraph.

3.2 For devices intended for clinical investigations, the documentation shall also contain:

-- a general description of the product,

-- design drawings, manufacturing methods, in particular as regards sterilisation, and diagrams of parts, sub-assemblies, circuits, etc.,

-- the descriptions and explanations necessary for the understanding of the said drawings and diagrams and of the operation of the product,

-- a list of the standards laid down in Article 5 of the Directive, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements of the Directive where the standards in Article 5 thereof have not been applied,

-- the results of the design calculations, checks and technical tests carried out, etc.

The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured confirm to the documentation referred to in 3.1 and in the first paragraph of this section.

The manufacturer may authorize the evaluation, by audit where necessary, of the effectiveness of these measures.

SCHEDULE 7.

(Corresponding to Annex 7 of the Directive).

Clinical Evaluation.

1. General provisions

1.1 Adequacy of the clinical data presented, as referred to in section 4.2 of Schedule 2, and in section 3 of Schedule 3, shall be based, account being taken as appropriate of the relevant harmonised standards, on either:

1.1.1 a collation of currently available relevant scientific literature covering the intended use of the device and the techniques therefore, as well as, if appropriate, a written report making a critical assessment of this collation; or

1.1.2 the results of all clinical investigations made, including those carried out in accordance with section 2.

1.2 All data must remain confidential unless it is deemed essential that they be divulged.

2. Clinical investigation

2.1 Purpose

The purpose of clinical investigation is to:

-- verify that, under normal conditions of use, the performances of the device comply with those indicated in section 2 of Schedule 1,

-- determine any undesirable side effects, under normal conditions of use, and assess whether they are acceptable risks having regard to the intended performance of the device.

2.2 Ethical consideration

Clinical investigations shall be made in accordance with the Declaration of Helsinki approved by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and amended by the 29th World Medical Assembly in Tokyo, Japan, in 1975 and the 35th World Medical Assembly in Venice, Italy, in 1983. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Declaration of Helsinki. This includes every step in the clinical investigation of the study to publication of results.

2.3 Methods

2.3.1 Clinical investigations shall be performed according to an appropriate state of the art plan of investigation defined in such a way as to confirm or refute the manufacturer's claims for the device; the investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions.

2.3.2 The procedures utilized to perform the investigations shall be appropriate to the device under examinations.

2.3.3 Clinical investigations shall be performed in circumstances equivalent to those which would be found in normal conditions of use of the device.

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

2.3.5 All adverse events shall be fully recorded.

2.3.6 The investigations shall be performed under the responsibility of a registered medical practitioner, in an appropriate environment. The registered medical practitioner shall have access to the technical data regarding the device.

2.3.7 The written report, signed by the responsible registered medical practitioner, shall comprise a critical evaluation of all the data collected during the clinical investigation.

SCHEDULE 8.

(Corresponding to Annex 8 of the Directive).

Minimum criteria to be met when designating inspection bodies to be notified.

1. The body, its Director and the staff responsible for carrying out the evaluation and verification operations shall not be the designer, manufacturer, supplier or installer of devices which they control, nor the authorized representative of any of those parties. They may not become directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2. The body and its staff must carry out the evaluation and verification operations with the highest degree of professional integrity and technical competence 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 verifications.

3. The body must be able to carry out all the tasks in one of Schedules 2 to 5 assigned to such a body and for which it has been notified, whether those tasks are carried out by the body itself for under its responsibility. In particular, it must have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with evaluation and verification; it must also have access to the equipment necessary for the verifications required.

4. The staff responsible for control operations must have:

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

-- satisfactory knowledge of the requirements of the controls they carry out and adequate experience of such operations,

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

5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of controls carried out, nor on the results of such controls.

6. The body must take out liability insurance unless liability is assumed by the State in accordance with national law, or the State itself is directly responsible for controls.

7. The staff of the body are bound to observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-á-vis the competent administrative authorities of the State in which their activities are carried out) under the Directive or any provision of national law giving effect to it.

SCHEDULE 9.

(Corresponding to Annex 9 of the Directive).

CE Conformity Marking.

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

-- If the CE 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 90/385/EEC of 20th July 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ No. L189, 20.7.90, p. 17).

The effect of these Regulations is:--

--to lay down essential safety requirements which active implantable 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.