Explanatory note

(This note is not part of the Regulations)

These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”).

Regulation 2 of these Regulations amends the 2002 Regulations by increasing the amounts of the fees specified in regulation 56 of those Regulations to cover the expertise required from external consultants in considering clinical investigations, further to the expansion of the definition of a medical device and consequent scope.

The 2002 Regulations contain the legislative measures necessary for the implementation of the European Union 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 devices^f1, Council Directive 93/42/EEC concerning medical devices^f2 and Council Directive 98/79/EC concerning in vitro diagnostic devices^f3.

The increase in fees is by approximately £800 in each instance when clinical investigation notices are under consideration, all other fees for medical devices remaining unchanged.

An impact assessment has not been prepared for this instrument as no impact on the private or voluntary sector is foreseen.

Annotations

Footnotes

f1: OJ No. L189, 20.7.90, p.17 to which amendments have been made by Council Directive 93/42/EEC, (OJ No. L169, 12.7.93, p.1) Council Directive 93/68/EEC (OJ No. L220, 30.8.1993, p.1), Regulation http://www.legislation.gov.uk/legislation/european/regulation/2003/1882(EC) No. 1882/2003 of the European Parliament and Council (OJ No. L284, 31.10.03, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 331, 7.12.1998, p.1).
f2: OJ No. L169, 12.7.93, p.1 to which amendments have been made by Directive 98/79/EC of the European Parliament and of the Council (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L313, 13.12.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L6, 10.1.2002, p.50), Regulation http://www.legislation.gov.uk/legislation/european/regulation/2003/1882 (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L284, 31.10.2003, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L94, 4.4.2007, p.23).
f3: OJ No. L331, 7.12.98, p.1 to which amendments have been made by Regulation http://www.legislation.gov.uk/legislation/european/regulation/2003/1882 (EC) No. 1882/2003 of the European Parliament and Council (OJ No.L284, 31.10.03, p.1), Regulation (EC) No. 596/2009 of the European Parliament and of the Council (OJ No. L188, 18.7.09, p.14) and Commission Directive 2011/100/EU (OJ No. L341, 22.12.11, p.50).