S.I. No. 576/2002 - European Communities (Medical Devices) (Amendment) Regulations, 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 7^th 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 assess the safety quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device.”;

(ii)  by the substitution for the second and third subparagraphs of Section 4.3 of the following:

“In the case of devices referred to in the first subparagraph of Paragraph 7.4 of Schedule 1, the notified body shall, as regards the aspects referred to in that section, consult one of the competent bodies designated by the Member States in accordance with Directive 65/65/EEC before taking a decision. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.

In the case of devices referred to in the second subparagraph of Section 7.4 of Schedule I, the scientific opinion of the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA”

(iii) by the addition of the following after Section 7:

“8. Application to the devices referred to in Regulation 3.3(a) herein:

Upon completing the manufacture of each batch of devices referred to in Regulation 3.3(a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 4(3) of Directive 89/381/EEC.”.

Amendments to Schedule III of the Principal Regulations

7.         (i) Section 3 of Schedule III of the Principal Regulations is hereby amended by the substitution for the sixth indent of the following:

“a declaration stating whether or not the device incorporates, as an integral part, a substance or human blood derivative, referred to in Section 7.4 of Schedule I and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device.”;

(ii) Section 5 of Schedule III of the Principal Regulations is hereby amended by the substitution for the second and third subparagraph of the following:

“In the case of devices referred to in the first subparagraph of Section 7.4 of Schedule 1, the notified body shall, as regards the aspects referred to in that section, consult one of the Competent Bodies designated by the Member States in accordance with Directive 65/65/EEC before taking a decision. The Notified Body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the Competent Body concerned.

In the case of devices referred to in the second subparagraph of Section 7.4 of Schedule 1, the scientific opinion of the EMEA must be included in the documentation concerning the device. The notified Body will give due consideration to the opinion of the EMEA when making its decision. The Notified Body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.”

Amendment to Schedule VI of the Principal Regulations.

8.         The title of Schedule VI of the Principal Regulations is hereby amended by the substitution of “Schedule IV” for the title

and by the insertion after Section 8 of the following Section 9:

“9. Application to devices referred to in Regulation 3.3(a) herein:

In the case of Section 5, upon completing the manufacture of each batch of devices referred to in Regulation 3.3(a), and in the case of verification under Section 6, the manufacturer shall inform the Notified Body of the release of this batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 4(3) of Directive 89/381/EEC.”

Amendment to Schedule V of the Principal Regulations

9.         Schedule V of the Principal Regulations is hereby amended by the insertion after Section 6 of the following:

“7. Application to devices referred to in Regulation 3.3(a):

Upon completing the manufacture of each batch of devices referred to in Regulation 3.3(a), the manufacturer shall inform the Notified Body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in he device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 4(3) of Directive 89/381/EEC.”

Amendment to Schedule 9 of the Principal Regulations

10.       Schedule 9, Part III classifications Section 4.1 Rule 13 is hereby amended by the addition of the following paragraph:

“All devices incorporating, as an integral part, a human blood derivative are in Class III.”

Transitional Provisions

11.       (1) Nothing in these regulations shall prohibit the placing on the market before 16^th November 2005 of a device if the supply of the device was permitted within the State on 13^th June 2002

(2) Nothing in these Regulations shall prohibit the putting into service before the 16^th November 2007 of a device to which paragraph (1) applies.

Amendment to the European Communities (In-Vitro Diagnostic Medical Devices) Regulations 2001 ( SI No 304 of 2001 )

12.       (1) Regulation 22(1) is hereby amended by the substitution of the 7^th day of December 2003 for the 27^th day October 2003.

(2) Regulation 22(2) is hereby amended by the substitution of the 7^th day of December 2005 for the 27^th day October 2005.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation)

These regulations amend the European Communities (Medical Devices) Regulations 1994 ( S.I. No. 252 of 1994 ) to give effect to Council Directives 2000/70/EC of 16^th November 2000 and 2001/104.EC of 7^th December 2001 as regards medical devices incorporating stable derivatives of human blood or human plasma.