# The Medical Devices (Fees Amendment) Regulations 2010

S.I. 2010/557 · made 25 February 2010

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”).

Made under: European Communities Act 1972 (repealed) (Section 2); Finance Act 1973 (Section 56)

PDFs: Printed copy https://openlegislation.uk/medical-devices-fees-amendment-regulations-2010/pdf/uksi_20100557_en.pdf; Explanatory Memorandum https://openlegislation.uk/medical-devices-fees-amendment-regulations-2010/pdf/uksiem_20100557_en.pdf

## Introductory text

Fees And Charges
Made 25th February 2010
Laid before Parliament 4th March 2010
Coming into force 1st April 2010
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and section 56(1) and (2) of the Finance Act 1973.
The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medical devices.
The Treasury has consented to the making of these Regulations as required by section 56(1) of the Finance Act 1973.

## 1 Citation and commencement

These Regulations may be cited as the Medical Devices (Fees Amendment) Regulations 2010 and shall come into force on 1st April 2010.

## 2 Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995

(1) The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 are amended as follows.
(2) In regulation 3 (fees)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£4,549” substitute “£4,595”; and
(ii) in sub-paragraph (b), for “£10,605” substitute “£10,711”;
(b) in paragraph (2)—
(i) in sub-paragraph (a), for “£900” substitute “£909”; and
(ii) in sub-paragraph (b), for “£2,517” substitute “£2,542”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,549” substitute “£4,595”; and
(ii) in sub-paragraph (b), for “£10,605” substitute “£10,711”;
(d) in paragraph (4)—
(i) in sub-paragraph (a), for “£900” substitute “£909”; and
(ii) in sub-paragraph (b), for “£2,517” substitute “£2,542”; and
(e) in paragraph (5)—
(i) in sub-paragraph (a), for “£46,531” substitute “£46,996”; and
(ii) in sub-paragraph (b), for “£11,552” substitute “£11,668”.
(3) In paragraph (2) of regulation 3A (fees for pre-consultation meetings)—
(a) in sub-paragraph (a), for “£824” substitute “£832”;
(b) in sub-paragraph (b), for “£1,044” substitute “£1,054”;
(c) in sub-paragraph (c), for “£1,428” substitute “£1,443”; and
(d) in sub-paragraph (d), for “£1,813” substitute “£1,831”.

## 3 Amendment of the Medical Devices Regulations 2002

(1) The Medical Devices Regulations 2002 are amended as follows.
(2) In regulation 54 (fees payable in connection with the designation etc of notified bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£930” substitute “£960”; and
(ii) in sub-paragraph (b), for “£3,700” substitute “£3,840”;
(b) in paragraph (2), for “£1,810” substitute “£1,880”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,500” substitute “£4,670”;
(ii) in sub-paragraph (b)(i), for “£7,400” substitute “£7,670”;
(iii) in sub-paragraph (b)(ii), for “£5,550” substitute “£5,760”;
(iv) in sub-paragraph (b)(iii), for “£3,700” substitute “£3,840”; and
(v) in sub-paragraph (c), for “£3,700” substitute “£3,840”; and
(d) in paragraph (3A)—
(i) in sub-paragraph (a)(i), for “£261” substitute “£271”; and
(ii) in sub-paragraph (a)(ii), for “£72.56” substitute “£75.24”.
(3) In regulation 55 (fees payable in connection with the designation etc of conformity assessment bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£930” substitute “£960”; and
(ii) in sub-paragraph (b), for “£3,700” substitute “£3,840”;
(b) in paragraph (2), for “£1,810” substitute “£1,880”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,500” substitute “£4,670”;
(ii) in sub-paragraph (b), for “£3,700” substitute “£3,840”;
(iii) in sub-paragraph (c), for “£1,810” substitute “£1,880”; and
(iv) in sub-paragraph (d), for “£3,700” substitute “£3,840”;
(d) in paragraph (3A), for “£4,500” substitute “£4,670” and for “£1,810” substitute “£1,880”;
(e) in paragraph (3B), for “£3,700” substitute “£3,840” and for “£1,810” substitute “£1,880”;
(f) in paragraph (3C), for “£1,810” substitute “£1,880”; and
(g) in paragraph (3D)—
(i) in sub-paragraph (a)(i), for “£261” substitute “£271”; and
(ii) in sub-paragraph (a)(ii), for “£72.56” substitute “£75.24”.

## Signature

Signed by authority of the Secretary of State for Health
Mike O’Brien
Minister of State,
Department of Health
22nd February 2010
We consent
Tony Cunningham
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
25th February 2010

## Explanatory note

(This note is not part of the Regulations)
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. 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 1%).
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 medical devices, Council Directive 93/42/EEC concerning medical devices and Council Directive 98/79/EC on in vitro diagnostic devices. Regulation 3 of these Regulations amends regulations 54 and 55 of the 2002 Regulations, which provide for the fees payable in connection with the designation etc of UK notified bodies and EU conformity assessment bodies. The overall increase in fees to the medical devices sector is 1%, as all other fees remain unchanged.
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 and copies have been placed in the libraries of both Houses of Parliament.

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Source: https://www.legislation.gov.uk/uksi/2010/557 (the official version)
Page: https://openlegislation.uk/medical-devices-fees-amendment-regulations-2010
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.