S.I. No. 92/2007 - European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 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 (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 (b) of the Principal Regulations. | ||
6. Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 9 (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 (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 (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 (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 (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. | ||
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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. | ||