EU Medical Devices (Amendment) Regulations 2012 have been published

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Marc

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#2
The introduction in brief:

STATUTORY INSTRUMENTS
2012 No. 1426 CONSUMER PROTECTION
The Medical Devices (Amendment) Regulations 2012

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.
 
#3
Just a word of explanation.

This is a amendment to UK law (a "Statutory Instrument") and collects the various changes to the European medical device directives (AIMDD, MDD and IVDD) and makes them part of UK law. It does not introduce any additional requirements.
 
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