Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements under Regulation (EU) 2017/745.

The guide “Clinical evaluation – Summary of safety and clinical performance (SSCP) – Regulation (EU) 2017/745” covers devices with a medical purpose and products without a medical purpose without a medical purpose listed in Annex XVI of Regulation (EU) 2017/745.

This guide recalls the principles of clinical evaluation and describes the different elements to be included in:

• The clinical evaluation plan;
• The clinical evaluation report;
• The post-market surveillance plan including the post-market clinical follow-up (PMCF) plan;
• The PMCF evaluation report.

All these documents are part of the technical documentation, within the framework of CE marking procedures for devices, regardless of the device class.

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