CONSUMER PROTECTION Citation and commencement 1 These Regulations may be cited as the Active Implantable Medical Devices Regulations 1992 and shall come into force on 1st January 1993. Interpretation 2 1 In these Regulations, unless the context requires otherwise— “the 1987 Act ” means the Consumer Protection Act 1987; “authorised representative” means an authorised representative established within the European Economic Community; “custom—made” means, in relation to a device, that it is manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific charac teristics as to its design, and that it is intended to be used only for a particular patient; “device” means an active implantable medical device, that is to say an instrument, apparatus, appliance, material or other article, whether used alone or in combina tion, together with any accessories or software necessary for its proper functioning, which— is intended by the manufacturer to be used for human beings— in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, in the investigation, replacement or modification of the anatomy or of a physiological process, or in the control of conception; does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, even if it is assisted in its function by such means; 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 is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced; even if it is intended to administer a medicinal product as defined in the Medicines Act 1968 or incorporates as an integral part a substance which, if used separately, would be a medicinal product as so defined; “ the Directive ” means Council Directive 90/385/ EEC on the approximation of the laws of member States relating to active implantable medical devices ; “ EC mark” means the mark which indicates that one or more of the procedures referred to in regulation 5 has been followed and which consists of a symbol comprising the letters “CE” of which an illustration is given in Schedule 1; “essential requirements” means the requirements specified in Schedule 2 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 the 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 Economic Community pursuant to Council Directive 83/189/EEC 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 and Council Directive 90/320/EEC , and 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 medical specialist when conducting clinical investigations of that device; “intended purpose” means, in relation to a device, the use for which it is intended and for which it is suited according to the data supplied by the manufacturer in the instructions relating to it; “medical specialist” means a registered medical practitioner who has a qualification as, or is undergoing training intended to lead to qualification as, a specialist; “member State” means a member State of the European Economic Community; “notified body” means, in relation to any task, a body designated and notified in respect of that task in accordance with Article 11 of the Directive; “placed on the market” means, in relation to a device, first supplied or first made available for supply in the United Kingdom otherwise than for the purpose of its export— to another country which is not a member State, and for use in a country that is not a member State; “put into service” means make available to registered medical practitioners for implantation; “relevant national Standard” means, in relation to an essential requirement or an aspect of it, a Standard— which contains a technical specification or a description relating to that requirement or aspect, which corresponds to a harmonised Standard containing such a specification or description, and of which the reference number is published in the United Kingdom by the Secretary of State by notice in the London, Edinburgh and Belfast Gazettes or in another member State of the European Economic Community; “relevant notified body logo” means the logo of the notified body which was responsible for carrying out tasks of the notified body under paragraph 5 of Annex 2 to, under Annex 4 to, or under paragraph 4 of Annex 5 to, the Directive 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 logo of each of them. 2 In these Regulations, unless the context requires otherwise, a reference to a numbered regulation is a reference to the regulation of these Regulations which is so numbered; a reference in a regulation of, or Schedule to, these Regulations to a numbered paragraph is a reference to the paragraph of that regulation or Schedule which is so numbered, and a reference in a paragraph to a numbered sub—paragraph is a reference to the sub—paragraph of that paragraph which is so numbered. Essential requirements for devices 3 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 of the essential requirements specified in paragraphs 1 to 5 of Schedule 2, 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 to in paragraph 1 of Schedule 3; 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 paragraphs 13, 14 and 15 of Schedule 2 are complied with only if the information and particulars referred to in those paragraphs are in English (whether or not they are also in another language). 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 grounds for suspecting 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 EC mark shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements. 7 A custom—made device in respect of which the conditions specified in Schedule 4 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Schedule 4 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting 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 regulation 7(1); b no notice has been given under regulation 7(2) within the period of 60 days there referred to; and c the conditions specified in Schedule 4 are satisfied, shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements. EC mark 4 1 Except as provided by paragraph (2), every device placed on the market or put into service shall bear the EC mark (affixed following a procedure mentioned in regulation 5, whether carried out in the United Kingdom 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 logo for that device. 2 Paragraph (1) does not apply to a device which is custom—made or intended for clinical investigation, and such devices shall not bear the EC mark. 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 EC mark. Procedure for affixing EC mark 5 1 A device may bear the EC mark 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 EC mark in accordance with regulation 4, 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 5 (Part I of which relates to the quality system, including the design dossier, and Part II of which relates to surveillance) 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 6 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 7 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 EC mark in accordance with regulation 4, 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 8 (Part I of which relates to the quality system and inspection and Part II of which relates to surveillance) 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 in the United Kingdom by a manufacturer who has no place of business there may instead be followed by his authorised representative. 7 The documentation relating to any of the procedures mentioned in this regulation carried out in the United Kingdom shall be in English or, subject to regulation 3(4), in some other language acceptable to the notified body concerned. 8 A notified body may charge a fee in accordance with paragraphs (9), (10) and (11) for anything done in, or in connection with, performing a function under this regulation or under any of the Schedules referred to in it. 9 Except as provided by paragraph (10) the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it. 10 Where the notified body is a body the activities of which are carried on for profit, the fee for doing anything may include an amount representing a profit which is reasonable in the circumstances, having regard to — a the character and extent of the work done or to be done by the notified body; and b the commercial rate normally charged in respect of profit for that work or similar work. 11 The notified body may require payment of a fee or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work. Custom—made devices 6 1 The manufacturer of a custom—made device shall — a satisfy the conditions specified in Schedule 4 (as it applies to custom—made devices) before that device is placed on the market or put into service; and b take all necessary measures to ensure that the manufacturing process ensures that the device manufactured to that process conforms to the documentation referred to in paragraph 3(a) of Schedule 4. 2 The conditions specified in paragraph 1 of Schedule 4 may be satisfied by the manufacturer’s authorised representative, instead of by the manufacturer. Clinical investigations 7 1 Before devices intended for clinical investigation are made available to a medical specialist for the purposes of a clinical investigation to take place within the United Kingdom their manufacturer or his authorised representative shall give at least 60 days' prior notice in writing to the Secretary of State of the making available of the devices for the intended investigation, in the form of the statement provided for by paragraphs 1 and 2(2) of Schedule 4 and the undertaking by the manufacturer mentioned in paragraph 3 of that Schedule. 2 If, within 60 days of the giving of that notice, the Secretary of State gives written notice to the manufacturer or his authorised representative, whichever gave the notice to him under paragraph (1), 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 paragraph (1). 3 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 paragraph 3(b) of Schedule 4 and may authorise the evaluation, by audit where necessary, of the effectiveness of the measures which he takes pursuant to Schedule 4. 4 A manufacturer who has given the undertaking mentioned in paragraph (1) shall, if so required by the Secretary of State for the purposes of his functions under paragraph (2), make available to him the documentation which he has undertaken to keep available. 5 The grounds on which a notice may be given under paragraph (2) include the grounds that the Secretary of State is not satisfied as to the safety of a device for the intended purposes because— a the manufacturer does not authorise an evaluation by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (3); or b the manufacturer does not make available to the Secretary of State documenta tion which he has undertaken to keep available. Notified bodies 8 1 The Secretary of State may approve for the purposes of Article 11 of the Directive any corporate or other body as a body which is to carry out tasks as part of a procedure mentioned in regulation 5 and, if he so approves a body, he shall designate the tasks which it is to carry out. 2 A body shall be approved under paragraph (1) only if— a it has applied to be, or agrees to be, so approved; b it is a body in respect of which the conditions specified in Schedule 9 are fulfilled as respects the tasks which it is to carry out. 3 The Secretary of State shall withdraw any approval of a body under paragraph (1) if the body so requests or if he considers that it is no longer a body in respect of which the conditions specified in Schedule 9 are fulfilled as respects the tasks which it is to carry out. 4 The Secretary of State may vary the designation of tasks which a notified body is to carry out by— a limiting or removing the tasks; or b on the application of the notified body, extending or adding to the tasks. 5 Before withdrawing an approval under paragraph (3), otherwise than at the notified body’s request, and before effecting a variation under paragraph (4)(a), the Secretary of State shall give to the notified body an opportunity to make representations to him in writing and shall take into account any such representations as are made. Prohibition on supply etc. 9 1 Subject to paragraph (6), the supply, offer to supply, agreement to supply, exposure for supply or possession for supply of a device which has been placed on the market or put into service and which does not comply with the relevant essential requirements is prohibited. 2 Subject to paragraphs (3) and (6) the supply, offer to supply, agreement to supply, exposure for supply or possession for supply of a device— a which does not bear the EC mark as required by regulation 4(1); or b which bears a mark in contravention of regulation 4(3), is prohibited. 3 Paragraph (2)(a) does not apply to a device which is custom—made or intended for clinical investigation. 4 The supply of a custom—made device in respect of which the manufacturer or his authorised representative has contravened regulation 6 is prohibited. 5 The supply, in contravention of regulation 7(1) or a notice under regulation 7(2), of a device intended for clinical investigation is prohibited. 6 Nothing in paragraph (1) or (2) prevents the offer to supply, the exposure for supply or the possession for supply 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 EC mark 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 put into service until it complies with the requirements of the Directive. Enforcement etc. 10 1 Notwithstanding that they are made partly in exercise of powers other than those conferred by section 11 of the 1987 Act these Regulations shall be regarded for all purposes relating to enforcement (whether by criminal proceedings or notices or otherwise) and for the purposes of section 38 of that Act (disclosure of information) as safety regulations as defined in that Act and any provision of these Regulations made under those other powers shall be regarded for those purposes as a safety provision as defined in that Act. 2 Each weights and measures authority and each district council in Northern Ireland is relieved of its duty imposed by section 27(1) of the 1987 Act in so far as it is exercisable in relation to devices. 3 The powers conferred by section 13 of the 1987 Act to serve prohibition notices and notices to warn are exercisable in relation to non—conforming devices as they are exercisable in relation to relevant goods which the Secretary of State considers are unsafe (as well as being exercisable in relation to such goods), and in relation to non—conforming devices Schedule 2 to the 1987 Act shall have effect as if references to goods being unsafe or safe were references to devices being or not being non—conforming devices. 4 In paragraph (3) “non—conforming devices” means devices which, whether or not the Secretary of State considers them unsafe, he considers to be devices to which the EC mark has been wrongly applied and to be devices— a which do not conform as respects a relevant essential requirement to a relevant national Standard where the device is held out as respects that essential requirement as conforming to that Standard; or b where the devices are ones to which the EC mark has been applied following the EC declaration of conformity procedure, in respect of which the manufacturer or his authorised representative has failed to comply with his obligations under that procedure; or c where the devices are ones to which the EC mark has been applied following the EC type—examination procedure, which do not conform to the type described in the relevant EC type—examination certificate or which conform to such a type which does not meet the relevant essential requirements. Transitional provision 11 Nothing in regulation 9(1), (2) or (4) shall prohibit the supply before 1st January 1995 of a device, if the supply of the device is in accordance with the laws of that part of the United Kingdom in which it is supplied as in force on 31st December 1992. Notification of decisions etc. 12 1 Where a decision is taken by the Secretary of State or a notified body under these Regulations which results in the refusal of, or restrictions on, the placing on the market by, or the putting into service by, a person of a device, the Secretary of State who, or the notified body which, took the decision shall forthwith give to that person notice of the decision which shall include— a a statement of the grounds on which it is based; and b a statement of any legal remedies available to that person and of any time limits which apply to their exercise. 2 The provisions of paragraph (1) are in addition to any more specific obligation placed upon the Secretary of State or the notified body elsewhere in these Regulations. Virginia Bottomley One of Her Majesty’s Principal Secretaries of State 10th December 1992 Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 10th day of December 1992. F. A. Elliott Permanent Secretary