Medical Devices 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.

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 medical devices, regardless of the medical device class.

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