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The Medical Devices (Amendment) Regulations 2007
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- UK Statutory Instruments
- 2007 No. 400
- Regulation 2
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Amendment of regulation 2 of the principal Regulations
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2. In regulation 2 of the principal Regulations (interpretation), in paragraph (1)—
(a)after the definition of “Directive 2003/32” insert—
““Directive 2005/50” means Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices(1);”; and
(b)after the definition of “harmonised standard” insert—
““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, other than ancillary components (screws, wedges, plates and instruments);”.
(1)
OJ No. L210, 12.8.2005, p.41.
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