S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 (2003_si_358) | IE

ISB SI

Reg. 1 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 Open official source

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

ISB SI

Reg. 2 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 Open official source

2. These Regulations shall come into force on 1

st

day of September, 2003.

Definitions

In these Regulations

ISB SI

Reg. 3 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 Open official source

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

ISB SI

Reg. 4 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 Open official source

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

ISB SI

Reg. 5 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 Open official source

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.

ISB SI

Reg. 6 S.I. No. 358/2003 - European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003 Open official source

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.

GIVEN under my Official Seal,

This 25th day of July, 2003

________________________

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 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.

ISB SI

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

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

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

Table of Provisions (7)

Statutory Text (7 Articles)

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