S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003

S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 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 2003 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 AmendmentsLeasuithe 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 93/42/EEC of 14 June, 1993 and Commission Directive 2003/12/EC of 3 February, 2003, on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices, hereby make the following Regulations: Citation and commencement 1. These Regulations may be cited as the European Communities (Medical Devices) (Amendment) Regulations, 2003. 2. These Regulations shall come into force on 1st day of September, 2003. Definitions In these Regulations: 3. “The Principal Regulations” means the European Communities (Medical Devices Regulations, 1994 ( S.I. No. 252 of 1994 ). Amendment to Schedule 9 of the Principal Regulations 4. By way of derogation from the Classification Criteria set out in Schedule 9 of the Principal Regulations breast implants shall be reclassified as medical devices falling within Class 111. Amendment to Article 9 of the Principal Regulations 5. Breast implants placed on the market before 1 September, 2003 pursuant to Article 9 (
4. a)or 9 (
5. b)(iii) of the Principal Regulations shall be subject to a conformity reassessment procedure as Class 111 medical devices before 1 March 2004. 6. By way of derogation from Articles 12