Class III Medical Devices (Conformity Assessment) – 验证评估程序——III 级
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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.
- 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