Summary of Safety and Clinical Performance guidance published to support the implementation of the MDR

Posted on 03.10.2019

According to Article 32 of the Medical Device Regulation, the manufacturer shall draw up a summary of safety and clinical performance for implantable devices and for class III devices, other than custom-made or investigational devices.

Medical Device Coordination Group Document adopted the related MDCG 2019-9 Summary of safety and clinical performance guide for (medical device) manufacturers and notified bodies which was made available at DG GROW’s website on 27 September 2019.

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