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.