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The Medical Devices (Fees Amendment) Regulations 2013

S.I. 2013/525 · Made 7 March 2013

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Fees And Charges

Made 7th March 2013

Laid before Parliament 11th March 2013

Coming into force 1st April 2013

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972f1 and section 56(1) and (2) of the Finance Act 1973f2.

The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972f3 in relation to medical devices.

Annotations to the whole text

Footnotes

f1

1972 c.68. Under section 57(1) of the Scotland Act 1998 (c.46), despite the transfer to Scottish Ministers of functions in relation to implementing obligations under European Union law in relation to devolved matters, the functions of the Secretary of State in relation to implementing these obligations continues to be exercisable by the Secretary of State as regards Scotland.

f2

1973 c.51.

f3

The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289 and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.

Contents

  1. 1Citation and commencement
  2. 2Amendment of the Medical Devices Regulations 2002
  3. Signature
  4. Explanatory note

1Citation and commencement

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

2Amendment of the Medical Devices Regulations 2002

(1)

Regulation 56 (fees payable in relation to clinical investigation notices) of the Medical Devices Regulations 2002f1 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”.

Signature

Signed by authority of the Secretary of State for Health.

Earl Howe

Parliamentary Under-Secretary of State,

Department of Health

1st March 2013

We consent

Desmond Swayne

Stephen Crabb

Two of the Lords Commissioners of Her Majesty’s Treasury

7th March 2013

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 devicesf1, Council Directive 93/42/EEC concerning medical devicesf2 and Council Directive 98/79/EC concerning in vitro diagnostic devicesf3.

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.