European Communities (Medical Devices) (Amendment) Regulations, 2002

• Jurisdiction: Ireland
• Citation: IR SI 576/2002

I, Micheál Martin, Minister for Health and Children, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 , (No. 27 of 1972) and for the purpose of giving full effect to Council Directive 2000/70/EC of 16 November 2000 and Council Directive 2001/104/EC of 7th December 2001 both of which amend Council Directive 93/42/EEC of 14 June 1993 with regards to medical devices incorporating stable derivative of human blood or human plasma, hereby make the following Regulations:
	Citation	1. These Regulations may be cited as the European Communities (Medical Devices (Amendment) Regulations, 2002.
	In these Regulations	2. “The Principal Regulations” means the European Communities (Medical Devices Regulations, 1994 ( S.I. No. 252 of 1994 ).
	Amendment to the Irish Medicines Board Act 1995	3. Section 9 of the Irish Medicines Board Act 1995 is hereby amended by the insertion of the following paragraph after paragraph 9(1) (b)
“(c) a committee to be known as the Advisory Committee for Medical Devices to assist and advise the Board in relation to any matters pertaining to the safety, quality and efficacy of medical devices as are referred to it by the Board.”
	Amendments to Section 3 of the Principal Regulations	4. Regulation 3 of the Principal Regulations is hereby amended as follows:
(i) by the insertion of the following paragraph after subsection (3):
“(3)(a) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 89/381/EEC and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device must be assessed and authorised in accordance with the Directive 93/42/EEC and these Regulations.”
(ii) by the substitution in Section (4)(c) of the following:
“(c) medicinal products covered by Directive 65/65/EEC, including medicinal products derived from blood as covered by Directive 89/381/EEC;”
(iii) by the substitution in Section (4)(e) of the following:
“human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells, with the exception of devices referred to in Regulation 3 (3)(a) herein;”.
1 OJ L 169, 12.7.1993, p.l. directive as amended by Directive 98/79/EC of the European Parliament and of the Council (OJ L 331, 7.12.1998, p.l.)
2 Directive 98/79/EC of the European parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices (OJ L 331, 7.12.)
	Amendments to Schedule I of the Principal Regulations	5. Schedule I of the Principal Regulations is hereby amended as follows
(i) by the addition of the following subparagraphs to Section 7.4 as follows:
“Where a device incorporates, as an integral part, a human blood derivative, the notified body shall seek a scientific option from the European Agency for the evaluation of the medicinal products (EMEA) on the quality and safety of the derivative, taking account of the appropriate Community provisions and, in particular, by analogy with the provisions and of Directives 75/318/EEC and 89/381/EEC. The usefulness of the derivative as a part of the medical device shall be verified, taking account of the intended purpose of the device.
In accordance with Article 4(3) of Directive 89/381/EEC, a sample from each batch of bulk and/or finished product of the human blood derivative shall be tested by a State laboratory designated for that purpose by a Member State.”
(ii) by the addition of the following subparagraph to Section 13.3:
“(n) in the case of a device within the meaning of Regulation 3(3)(a) herein, an indication that the device contains a human blood derivative.”
	Amendments to Schedule II of the Principal Regulations	6. Schedule II is hereby amended as follows:
(i) by the substitution of the following for the fifth indent of Section 3.2(c):
“a statement indicating whether or not the device incorporates, as an integral part a substance or a human blood derivative referred to in Section 7.4 of Schedule 1 and the data on the tests conducted in this connection required to...