S.I. No. 576/2002 - European Communities (Medical Devices) (Amendment) Regulations, 2002 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach En
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
Article 4
(3)of Directive 89/381/EEC.” Amendment to Schedule V of the Principal Regulations
- Schedule V of the Principal Regulations is hereby amended by the insertion after Section 6 of the following: “
- 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
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 16th November 2005 of a device if the supply of the device was permitted within the State on 13th June 2002
(2)Nothing in these Regulations shall prohibit the putting into service before the 16th 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 7th day of December 2003 for the 27th day October 2003.
(2)Regulation 22
(2)is hereby amended by the substitution of the 7th day of December 2005 for the 27th day October
- GIVEN under the Official Seal of the Official Seal of the Minister for Health and Children, this 11th day of December,
- ________________________ Micheál Martin Minister for Health and Children 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 16th November 2000 and 2001/104.EC of 7th December 2001 as regards medical devices incorporating stable derivatives of human blood or human plasma. Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais