Citation and commencement

1. These Regulations may be cited as the Medical Devices (Fees Amendment) Regulations 2013 and shall come into force on 1st April 2013.

Amendment of the Medical Devices Regulations 2002

2.-(1) Regulation 56 (fees payable in relation to clinical investigation notices) of the Medical Devices Regulations 2002(4) is amended as follows.

(2) in paragraph (1)-

(a)in sub-paragraph (a), for "£2,120" substitute "£2,920" and for "£2,770" substitute "£3,570";

(b)in sub-paragraph (b), for "£3,020" substitute "£3,820" and for "£4,240" substitute "£5,040".

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(5), Council Directive 93/42/EEC concerning medical devices(6) and Council Directive 98/79/EC concerning in vitro diagnostic devices(7).

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.