Jul 8, 2016

Revised European guidance on Clinical Evaluation Reports (CER) for medical devices takes a more comprehensive approach to total-product-lifecycle issues and introduces more thorough pre- and most-market data requirements.

According to an initial analysis of MEDDEV 2.7/1, Rev. 4 covering CERs by Emergo consultants, the latest revision of the guidance incorporates more comprehensive considerations for risk management, clinical data and post-market surveillance. While Emergo has always understood this to be the case, this is now more formally documented.

The guidance also includes additional recommendations in Appendix A.1 regarding device equivalence and incorporation of such data in CERs. Evangeline Loh, Vice President of Global Regulatory Affairs at Emergo, notes that manufacturers should pay more attention to equivalence issues, because European regulators will certainly be doing so.

“Equivalence will need to be much more rigorously documented and reviewed, since this will be more critically reviewed by Notified Bodies and Competent Authorities,” says Loh. “Manufacturers claiming equivalence in their CERs will need to be sure that their devices are truly equivalent—that is, that there is no clinically significant difference in terms of performance and safety, as stated in the updated MEDDEV, between a device and its identified equivalent.”

Although the updated clinical evaluation guidance pertains to Europe’s current medical device and active implantable medical device Directives, it also aligns closely with the concept of equivalence included in the draft Medical Device Regulations (MDR) expected to go into effect in the next few years.


  • Stewart Eisenhart