According to MDR Article 32, for implantable devices and Class III devices, the manufacturer prepares a Summary of Safety and Clinical Performance (SSCP).

The SSCP is written in a manner that is understandable to the intended user and, where applicable, to the patient, and it is made publicly available through Eudamed.

The Instructions for Use (IFU) prepared by the manufacturer must contain everything needed to locate the SSCP directly in Eudamed.

Manufacturers of implantable devices and Class III devices update the SSCP as necessary and at least annually.

This report prepared by the manufacturer, in accordance with MDR Article 32, is approved for compliance by a Notified Body and uploaded to EUDAMED.

MDCG 2019-9 Summary of Safety and Clinical Performance (SSCP) – Guidance for Manufacturers and Notified Bodies.