MDCG 2022-9: Summary of Safety and Performance template under Regulation (EU) 2017/746

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies.

The MDCG (Medical Device Coordination Group) has published MDCG 2022-9 which proposes a template for the Summary of Safety and Performance (SSP). This summary shall be validated by a Notified Body and made available to the public via the European medical device database EUDAMED.

The SSP should include information dedicated to the intended user, and if relevant, the patient. The SSP shall be kept updated in EUDAMED.

The guide presents information to be indicated depending on whether the device is a self-diagnosis device or not.

DOWNLOAD THE MDCG 2022-9 DOCUMENT