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

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:

1.         These Regulations may be cited as the European Communities (Medical Devices) (Amendment) Regulations, 2003.

2.         These Regulations shall come into force on 1^st day of September, 2003.

In these Regulations:

3.         “The 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 breast implants shall be reclassified as medical devices falling within Class 111.

5.         Breast implants placed on the market before 1 September, 2003 pursuant to Article 9 (a) or 9 (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(6) and 12 (7) of the Principal Regulations the decisions on breast implants taken by the Notified Bodies before 1 September under Article 9(a) cannot be extended.

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 2003/12/EC of 3 February, 2003, as regards the reclassification of breast implants to the higher classification of class III medical devices.