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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