Summary of Safety and Clinical Performance (SSCP)

Pursuant to MDR Clause 32, the manufacturer prepares a safety and clinical performance summary (SSCP) for implantable devices and Class III devices.

The safety and clinical performance summary is written in a manner that is understandable to the intended user and, if relevant, the patient, and is available to the public through Eudamed.

Instruction for Use (IFU) to be prepared by the manufacturer should contain everything needed to find the SSCP directly on Eudamed.

Manufacturers of implantable and class III devices update the SSCP as needed and at least annually. Pursuant to MDR Article 32, this report prepared by the manufacturer is approved by the Notified Body and uploaded to EUDAMED.

MDCG 2019-9 Summary of Safety and Clinical Performance -SSCP-Guidelines for Manufacturers and Notified Bodies.