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The Medical Devices (Amendment) Regulations 2008
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- UK Statutory Instruments
- 2008 No. 2936
- Regulation 12
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Amendment of regulation 21 of the principal Regulations
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12. In regulation 21 of the principal Regulations (scope of Part III)—
(a)the existing paragraph shall be numbered (1); and
(b)after paragraph 1 add—
“(2) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.
(3) Where an active implantable medical device is intended to administer a medicinal product, that device shall be governed by Directive 90/385 without prejudice to the provisions of Directive 2001/83/EC.”.
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