Why New CER is Complex?

In July’2016, the EU has published Rev.4 of MEDDEV 2.7.1 on clinical Evaluation for medical devices. The new guidance document describes the requirements in a more detailed and prescriptive manner, in order to execute an adequate clinical evaluation of your devices. Throughout the new guidelines, it emphasizes on how to perform the process, document the results in a clinical evaluation report, include it in the technical documentation, and submit it to a Notified Body for review.