# The Medical Devices (Fees Amendments) Regulations 2009

S.I. 2009/383 · made 23 February 2009

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Made under: European Communities Act 1972 (repealed) (Section 2); Finance Act 1973 (Section 56)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-amendments-regulations-2009/pdf/uksi_20090383_en.pdf; Explanatory Memorandum https://openlegislation.uk/medical-devices-fees-amendments-regulations-2009/pdf/uksiem_20090383_en.pdf

## Introductory text

Fees And Charges
Made 23rd February 2009
Laid before Parliament 3rd March 2009
Coming into force 1st April 2009
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 Amendments) Regulations 2009 and shall come into force on 1st April 2009.

## 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 “£4,374” substitute “£4,549”; and
(ii) in sub-paragraph (b), for “£10,197” substitute “£10,605”;
(b) in paragraph (2)—
(i) in sub-paragraph (a), for “£865” substitute “£900”; and
(ii) in sub-paragraph (b), for “£2,420” substitute “£2,517”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,374” substitute “£4,549”; and
(ii) in sub-paragraph (b), for “£10,197” substitute “£10,605”;
(d) in paragraph (4)—
(i) in sub-paragraph (a), for “£865” substitute “£900”; and
(ii) in sub-paragraph (b), for “£2,420” substitute “£2,517”; and
(e) in paragraph (5)—
(i) in sub-paragraph (a), for “£44,741” substitute “£46,531”; and
(ii) in sub-paragraph (b), for “£11,108” substitute “£11,552”.
(3) In paragraph (2) of regulation 3A (fees for pre-consultation meetings)—
(a) in sub-paragraph (a), for “£792” substitute “£824”;
(b) in sub-paragraph (b), for “£1,004” substitute “£1,044”;
(c) in sub-paragraph (c), for “£1,373” substitute “£1,428”; and
(d) in sub-paragraph (d), for “£1,173” substitute “£1,813”.

## 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 UK notified bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£900” substitute “£930”; and
(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;
(b) in paragraph (2), for “£1,800” substitute “£1,810”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,400” substitute “£4,500”;
(ii) in sub-paragraph (b)(i), for “£7,200” substitute “£7,400”;
(iii) in sub-paragraph (b)(ii), for “£5,400” substitute “£5,550”;
(iv) in sub-paragraph (b)(iii), for “£3,600” substitute “£3,700”; and
(v) in sub-paragraph (c), for “£3,600” substitute “£3,700”; and
(d) in paragraph (3A)—
(i) in sub-paragraph (a)(i), for “£254” substitute “£261”; and
(ii) in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.
(3) In regulation 55 (fees payable in connection with the designation etc of EC conformity assessment bodies)—
(a) in paragraph (1)—
(i) in sub-paragraph (a), for “£900” substitute “£930”; and
(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;
(b) in paragraph (2), for “£1,800” substitute “£1,810”;
(c) in paragraph (3)—
(i) in sub-paragraph (a), for “£4,400” substitute “£4,500”;
(ii) in sub-paragraph (b), for “£3,600” substitute “£3,700”;
(iii) in sub-paragraph (c), for “£1,800” substitute “£1,810”; and
(iv) in sub-paragraph (d), for “£3,600” substitute “£3,700”;
(d) in paragraph (3A), for “£4,400” substitute “£4,500” and for “£1,800” substitute “£1,810”;
(e) in paragraph (3B), for “£3,600” substitute “£3,700” and for “£1,800” substitute “£1,810”;
(f) in paragraph (3C), for “£1,800” substitute “£1,810”; and
(g) in paragraph (3D)—
(i) in sub-paragraph (a)(i), for “£254” substitute “£261”; and
(ii) in sub-paragraph (a)(ii), for “£70.45” substitute “£72.56”.
(4) In regulation 56 (fees payable in relation to clinical investigation notices), in paragraph (1)—
(a) in sub-paragraph (a), for “£2,100” substitute “£2,120” and for “£2,700” substitute “£2,770”; and
(b) in sub-paragraph (b), for “£3,000” substitute “£3,020” and for “£4,100” substitute “£4,240”.

## Signature

Signed by authority of the Secretary of State for Health.
Dawn Primarolo
Minister of State,
Department of Health
9th February 2009
We consent
Tony Cunningham
Dave Watts
Two of the Lords Commissioners of Her Majesty’s Treasury
23rd February 2009

## 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 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, 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 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.

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Source: https://www.legislation.gov.uk/uksi/2009/383 (the official version)
Page: https://openlegislation.uk/medical-devices-fees-amendments-regulations-2009
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.