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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