MDD Article 3 Essential Requirements

93 42 EEC Medical Devices Directive

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The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.

Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on 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 this Directive.

Medical Devices Directive

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- - Validation. Classification. Regulation. Requirements. Current best practices.
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