Statutory Instruments
2012 No. 1426
Consumer Protection
The Medical Devices (Amendment) Regulations 2012
Made
29th May 2012
Laid before Parliament
11th June 2012
Coming into force
1st July 2012
The Secretary of State makes the following Regulations, in exercise of the powers conferred on him by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972(1) and section 11 of the Consumer Protection Act 1987(2). He is designated for the purpose of section 2(2) of the European Communities Act 1972 in relation to medical devices(3).
These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for references to Annexes 1 to 7 to Directive 90/385/EEC, Annexes I to X to Directive 93/42/EEC, and Annex I to X to Directive 98/79/EC to be construed as a reference to those provisions as are amended from time to time.
In accordance with section 11(5) of the Consumer Protection Act 1987, he has consulted such organisations as appeared to him to be representative of interests substantially affected by these Regulations, such other persons as he considered appropriate and the Health and Safety Executive.
1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 c.51, section 27(1)(a) and the European Union (Amendment) Act 2008 section 3(3) and Schedule Part 1.
1987 c.43; section 11 was amended by S.I.2005/1803 and 2008/960; there are other amendments but none are relevant.
Designation in relation to active implantable medical devices is by S.I.1991/2289 and for other devices is by S.I.1993/2661.