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The Medical Devices (Amendment) Regulations 2008

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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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