Explanatory note

These Regulations make amendments to the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the 1995 Regulations”) and the Medical Devices Regulations 2002 (“the 2002 Regulations”).

The 1995 Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC concerning medical devices^f1. Regulation 2 of these Regulations amends the 1995 Regulations by increasing the amounts of the fees specified in regulations 3 and 3A of those Regulations (overall average increase of 3%). The fee referred to in regulation 2(3)(d) is increased by £640 which is more than 3%. This increase takes account of the erroneous reduction of this particular fee made in regulation 2(3)(d) of the Medical Devices (Fees Amendments) Regulations 2008 (S.I. 2008/530).

The 2002 Regulations 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, set out in Council Directive 90/385/EEC on the approximation of the laws of Member States relating to active implantable medical devices^f2, Council Directive 93/42/EEC concerning medical devices and Council Directive 98/79/EC on in vitro diagnostic devices^f3. Regulation 3 of these Regulations amends regulations 54 to 56 of the 2002 Regulations, which provide for the fees payable in connection with the designation etc of UK notified bodies and EC conformity assessment bodies and the fees payable in relation to clinical investigation notices. The overall increase in fees is 3%.

An impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.