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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations 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 putting into service of medical devices, including Council Directive 93/42/EEC of 14th June 1993 concerning medical devices(6), as amended(7) (“the principal Directive”).

Regulations 2, 4 and 5 amend the principal Regulations to implement Commission Directive 2005/50/EC of 11 August 2004 on the reclassification of hip, knee and shoulder joint replacements in the framework of the principal Directive. Regulations 2 and 5 require hip, knee and shoulder joint replacements to be reclassified as Class III devices, from Class IIb. Regulation 4 inserts a new regulation 4A to make related transitional provision. In particular, manufacturers of replacements which have been subject to the conformity assessment procedure under Annex II to the principal Directive (full quality assurance), as that process applies to Class IIb devices, have until 1st September 2009 to ensure that their device is subject to a complementary assessment procedure under Section 4 of Annex II and has an EC design-examination certificate. Manufacturers of replacements which have been subject to the conformity assessment procedure under Annex III (EC-type examination) coupled with Annex VI (product quality assurance) have until 1st September 2010 to ensure their device has been subject to the conformity assessment procedures applicable to class III devices. In addition, new regulation 4A(5) provides that products which have been subject to the conformity assessment procedure under Annex III with Annex VI and which have been placed on the market before 1st September 2010, may be put into service (i.e. made available to the final user) after that date.

Regulation 3 amends regulation 3 of the principal Regulations (scope) so as to provide that the Regulations apply to active implantable medical devices or in vitro diagnostic medical devices, or accessories to such devices, if they–

(a) incorporate human blood, blood products, plasma or blood cells of human origin,

(b) are transplants or tissue or cells of human origin, or incorporate or are derived from such tissues or cells, or

(c) are transplants or tissuse or cells of animal origin (other than non-viable animal tissue).

Regulation 6 amends regulation 61 of the principal Regulations (enforcement etc.) so as to provide that the time limit for commencing criminal proceedings in respect of a contravention of the Regulations committed on or after 10th March 2007 is increased from twelve months to three years from the date of the offence or one year from the discovery of the offence by the prosecutor, whichever is the earlier.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business, and a Transposition Note in relation to the implementation of Commission Directive 2005/50/EC, is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Copies have been placed in the libraries of both Houses of Parliament.