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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