Regulation 2 Amendment of regulation 2 of the principal Regulations

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^f1;”; and

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);”.