European Communities (Active Implantable Medical Devices) Regulations, 1994

• Jurisdiction: Ireland

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 93/42/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 Citation and Commencement.	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 Interpretation.	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 Application.	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 Essential Requirements for devices.	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...