European Communities (Medical Devices) Regulations, 1994

• Jurisdiction: Ireland
• Year: 1994
• Citation: IR SI 252/1994

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 93/42/EEC of 14th June 1993(1) concerning medical devices hereby makes the following Regulations:
(1) OJ No. L169 12.7.1993, p.1.
	1 Citation and Commencement.	1. (1) These Regulations may be cited as the European Communities (Medical Devices) Regulations, 1994.
(2) ( a ) Article 17 of these Regulations shall come into effect generally on the 3rd day of August 1994.
( b ) These Regulations (other than article 17) shall come into operation on the 3rd day of August 1994 to give effect to article 17.
( c ) The provisions specified in paragraph (b) shall come into operation for all other purposes on the 1st day of January 1995.
	2 ..	2. (1) In these Regulations,
"accessory" means an article which, whilst not being a device, is intended specifically by its manufacturer to be used together with a device to enable the device to be used as intended by its manufacturer;
"authorised officer" means a person appointed under article 23 to be an authorised officer for the purposes of these Regulations;
"authorised representative" means an authorised representative established within the European Community;
"CE marking" means the EC mark of conformity consisting of the symbol 'CE'; a specimen form of which is set out in Schedule 12;
"custom-made" means, in relation to a device—
( a ) that it is manufactured specifically in accordance with a written prescription of a registered medical practitioner or a professional user which gives, under his responsibility, specific characteristics as to its design; and
( b ) that it is intended to be used only for a particular named patient;
but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the registered medical practitioner or professional user;
"device" means a medical device, that is to say an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which—
( a ) is intended by the manufacturer to be used for human beings for the purpose of—
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
(iii) investigation, replacement or modification of the anatomy or of a physiological process, or
(iv) control of conception; and
( b ) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means;
"the Directive" means Council Directive 93/42/EEC on the approximation of the laws of Member States relating to medical devices(2);
(2)OJ No. L169 12.7.1993, p.1.
"essential requirements" means the requirements specified in schedule 1 and "relevant essential requirements" in relation to a device means such of those requirements, or such aspects of those requirements, as apply to it, but excluding, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;
"harmonised standard" means—
( a ) a technical specification adopted by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or both of them, upon a remit from the Commission of the European Community pursuant to Council Directive 83/189/EEC(3) laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Council Directive 88/182/EEC(4) and Council Directive 90/320/EEC(5), and the reference of which has been published in the Official Journal of the European Communities; or
(3) OJ No. L109 26.4.1983, p.8.
(4) OJ No. L 81 26.3.1988, p.75.
(5) OJ No. L128 18.5.1990, p.15.
( b ) a monograph of the European Pharmacopoeia on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the reference of which has been published in the Official Journal of the European Communities;
"intended for clinical investigation" means, in relation to a device, that it is intended for use by a registered medicinal practitioner or a professional user when conducting investigations of that device in an adequate human clinical environment;
"intended purpose" means, in relation to a device, the use for which it is intended according to the data supplied by the manufacturer on the labelling, and in any instructions and any promotional materials relating to it;
"manufacturer" means the person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party;
"Member State" means a Member State of the European Union;
"the Minister" means the Minister for Health;
"notified body" means, in relation to any task, a body designated and notified in respect of that task in accordance with Article 16 of the Directive;
"placing on the market" means, in relation to a device, the first making available, whether in return for payment or free of charge, of a new or fully refurbished device other than a device intended for clinical investigation, with a view to distribution, use, or both, in the Community;
"putting into service" means, in relation to a device, making it ready for use in the State for the first time for its intended purpose;
"registered medical practitioner" has the meaning assigned by section of the Medical Practitioners Act 1978 ;
"relevant national standard" means, in relation to an essential requirement or an aspect of it—
( a ) a standard specification declared in accordance with Section 20 of the Industrial Research and Standards Act, 1961 (No. 20 of 1961), or
( b ) a standard declared or laid down by a body or person pursuant to the law of another Member State,
which conforms to a harmonised standard to which the Directive applies;
"relevant notified body identification number" means the identification number of the notified body which was responsible for carrying out tasks of the notified body under Schedule 2, 3, 4, 5, 6 or 7 as respects a procedure which has been followed by the manufacturer of a device, and, where there is more than one such notified body, means the identification number of each of them;
"used for in vitro diagnosis" means, in relation to a device, that it is a reagent, reagent product kit, instrument, equipment or system, whether used alone or in combination and that it is intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;
(2) A reference in these Regulations to an article or a Schedule which is not otherwise identified is to an article of, or a Schedule to, these Regulations.
(3) A reference in these Regulations to a paragraph or subarticle is to the paragraph or subarticle of the article in which the reference occurs.
(4) A reference in these Regulations to article of the Directive is to an Article of Council Directive 93/42/EEC(6).
(6) OJ No. L169 12.7.1993, p.1.
(5) A word or an expression which is used in these Regulations and is also used in the Directive has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Directive.
	3 Application.	3. (1) Subject to subarticle (4), these Regulations shall apply to medical devices and their accessories and, for the purposes of these Regulations, accessories shall be treated as devices in their own right.
(2) Where a device is intended to administer a medicinal product within the meaning of Article 1 of Council Directive 65/65/EEC(7), that device shall be governed by Directive 93/42/EEC and these regulations, without prejudice to the provisions of Directive 65/65/EEC with regard to the medicinal product.
(7) OJ No. L22 9.6.1965, p.369.
If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 65/65/EEC. The relevant essential requirements of Schedule 1 of these Regulations shall apply as far as safety and performance related device features are concerned.
(3) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorised in accordance with Directive 93/42/EEC and these Regulations.
(4) These Regulations shall not apply to—
( a ) devices used for in vitro diagnosis;
( b ) active implantable devices covered by Directive 90/385/EEC(8);
(8) OJ No. L189 20.7.1990, p.17.
( c ) medicinal products covered by Directive 65/65/EEC(9);
(9) OJ No. 22 9.6.1965, p.269.
( d ) cosmetic products covered by Directive 76/768/EEC(10);
(10) OJ No. L262 27.9.1976, p.169.
( e ) human blood, human blood products, human plasma or blood cells of human origin or devices which, incorporate at the time of placing on the market, such blood products, plasma or cells;
( f ) transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin;
( g ) transplants or tissues or cells of animal origin, unless a device is...