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S.I. No. 92/2007 - European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007

S.I. No. 92/2007 - European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.

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  3. s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2007 S.I. No. 92/2007 - European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 S.I. No. 92/2007 - European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 AmendmentsLeasuithe Download PDF Íoslódáil PDF S.I. No. 92 of 2007 EUROPEAN COMMUNITIES (MEDICAL DEVICES) (RECLASSIFICATION OF HIP, KNEE AND SHOULDER JOINT REPLACEMENTS) (AMENDMENT) REGULATIONS 2007 I, MARY HARNEY, 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 93/42/EEC of 14 June 1993 1 and Commission Directive 2005/50/EC of 11 August 2005 2 on the reclassification of hip, knee and shoulder joint replacements in the framework of Directive 93/42/EEC concerning medical devices, hereby make the following Regulations: Notice of the making of this Statutory Instrument was published in “Iris Oifigiúil” of 6th March, 2007. 1. These Regulations may be cited as the European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007. 2. These Regulations shall come into force on 1 September 2007. 3. In these Regulations: “Hip, knee or shoulder replacement” means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint. Ancillary components (screws, wedges, plates and instruments) are excluded from this definition; “Principal Regulations” means the European Communities (Medical Devices) Regulations 1994 ( S.I. No 252 of 1994 ). 4. By way of derogation from the Classification Criteria set out in Schedule 9 of the Principal Regulations, hip, knee and shoulder replacements shall be reclassified as medical devices falling within Class III. 5. Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 9 (
  4. a)of the Principal Regulations before 1 September 2007 shall be subject to a complementary conformity assessment under Section 4 of Schedule 2 of the Principal Regulations leading to an EC design examination certificate before 1 September 2009. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 10 (
  5. b)of the Principal Regulations. 6. Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 9 (
  6. b)(iii) of the Principal Regulations before 1 September 2007 may be subject to a conformity assessment as Class III medical devices pursuant to Article 10 (
  7. b)of the Principal Regulations before 1 September 2010. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 10 (
  8. a)of the Principal Regulations. 7. The placing on the market and the putting into service of hip, knee and shoulder replacements which are covered by a decision in accordance with Article 9 (
  9. a)of the Principal Regulations issued before 1 September 2007 shall be accepted until 1 September 2009. 8. The placing on the market of hip, knee and shoulder replacements which are covered by a decision in accordance with Article 9 (
  10. b)(iii) of the Principal Regulations issued before 1 September 2007 shall be accepted until 1 September 2010 and such total joint replacements can be permitted to be put into service beyond that date. GIVEN under my Official Seal 28 February 2007 MARY HARNEY 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 Commission Directive 2005/50/EC of 11 August, 2005, as regards the reclassification of hip, knee and shoulder joint replacements to the higher classification of Class III medical devices. 1 OJ No. L169, 12.7.1993 2 OJ No. L210, 12.8.2005 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

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