Regulation 21 Scope of Part IIIE1

The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, F2...

Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in F4Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 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.

Where an active implantable device is intended to administer a medicinal product, that device must be governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012.

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