Class III Medical Devices

ProductClass_i_iii

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For devices with a high risk to the users, meaning class III devices such as heart valves, the manufacturer has to follow one of the following procedures:

  • Procedures of EC declaration of conformity (full Quality System) according to Annex II (see above) and in addition an examination of the design by a Notified Body.

or

  • Procedures according to Annex III EC type examination together with one of the procedures:
    • EC verification according to Annex IV or
    • EC declaration of conformity (production QA) according to Annex V