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.