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The Medical Devices (Amendment) Regulations 2005

S.I. 2005/2909 · Made 18 October 2005

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.

CONSUMER PROTECTION

Made 18th October 2005

Laid before Parliament 25th October 2005

Coming into force 22nd November 2005

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972f1 in relation to measures relating to medical devicesf2, in exercise of the powers conferred by the said section 2(2), and in exercise of the powers conferred by section 27(2) of the Consumer Protection Act 1987f3, makes the following Regulations:

Annotations to the whole text

Footnotes

f1

1972 c. 68.

f2

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.

f3

1987 c. 43.

Contents

  1. 1Citation and commencement
  2. 2Amendment of regulation 61 of the Medical Devices Regulations 2002
  3. Signature
  4. Explanatory note

1Citation and commencement

These Regulations may be cited as the Medical Devices (Amendment) Regulations 2005 and shall come into force on 22nd November 2005.

2Amendment of regulation 61 of the Medical Devices Regulations 2002

In regulation 61 of the Medical Devices Regulations 2002 (enforcement etc.)f1—

(a)

in paragraph (3), omit “for the purposes of Part II of the 1987 Act”; and

(b)

after paragraph (7), insert the following paragraph—

“(7A)

In paragraph (3), “consumer goods” means any goods which are ordinarily intended for private use or consumption.”

Signature

Signed by authority of the Secretary of State for Health

Jane Kennedy

Minister of Health,

Department of Health

18th October 2005

Explanatory note

(This note is not part of the Regulations)

These Regulations further amend the Medical Devices Regulations 2002 (“the principal Regulations”), which contain the legislative measures necessary for the implementation of the European Community scheme for regulating the placing on the market and the putting into service of medical devices.

Regulation 2 amends regulation 61 of the principal Regulations, which makes provision for enforcement. Paragraph (3) of that regulation had the effect that local authorities had a duty to enforce the Regulations in so far as they related to “consumer goods”, as defined in section 10(7) of Part II of the Consumer Protection Act 1987. Section 10 has been repealed by the General Product Safety Regulations 2005 (SI 2005/1803). Regulation 2(a) removes the reference to Part II of the 1987 Act. Regulation 2(b) inserts regulation 61(7A), defining the term “consumer goods”, so that local authorities continue to have an obligation to enforce in relation to goods ordinarily intended for use by consumers.

A full regulatory impact assessment has not been produced for this instrument as it has no impact on the costs of business.