RDM MD clinical evaluation SSCP guide 720 RDM 0801 8a 0001It 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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