Writing of Summary of Safety and Clinical Performance (SSCP)

As per the MDR, Article 32, for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. Similarly, according to IVDR’s Article 29, for class C and D devices, other than devices for performance studies, the manufacturer shall prepare the summary of safety and performance. The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.

Importantly, the draft of the summary of safety and clinical performance shall be part of the documentation submitted to the Notified Body, involved in the conformity assessment process, pursuant to Article 52 and shall subsequently be validated by that entity. After its validation, the Notified Body shall upload the document to Eudamed, to enable public access. The manufacturer shall point on the label, or instructions for use, where such summary can be found.

Medidee’s Clinical Team has the adequate expertise to deliver concise and regulatory-compliant Summary of Safety and Performance for your device, either in the context of performing Clinical of Performance Evaluation, or independently based on the documentation (evidence) provided by the client.