# The Medical Devices (Amendment) Regulations 2007, Regulation 2: Amendment of regulation 2 of the principal Regulations


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;”; 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);”.

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Source: https://www.legislation.gov.uk/uksi/2007/400/regulation/2 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-regulations-2007/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.