Explanatory note

These Regulations further amend the Medical Devices Regulations 2002 (“the principal Regulations”), which contain the legislative measures necessary for the implementation of the European Community scheme for regulating the placing on the market and the putting into service of medical devices.

Regulation 2 amends regulation 61 of the principal Regulations, which makes provision for enforcement. Paragraph (3) of that regulation had the effect that local authorities had a duty to enforce the Regulations in so far as they related to “consumer goods”, as defined in section 10(7) of Part II of the Consumer Protection Act 1987. Section 10 has been repealed by the General Product Safety Regulations 2005 (SI 2005/1803). Regulation 2(a) removes the reference to Part II of the 1987 Act. Regulation 2(b) inserts regulation 61(7A), defining the term “consumer goods”, so that local authorities continue to have an obligation to enforce in relation to goods ordinarily intended for use by consumers.

A full regulatory impact assessment has not been produced for this instrument as it has no impact on the costs of business.