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

(Please click on the chart to get an enlarged view)

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