It is indispensable for manufacturers of medical devices of all risk classes: The clinical evaluation according to MDR. According to Regulation (EU) 2017 / 745 (MDR) and as part of the conformity assessment procedure, documentation is a prerequisite for successful market access and must be planned.
As part of the technical documentation, the clinical evaluation is the basis for a safe medical device. The legal requirements are all the greater for this. But what exactly is the purpose of the clinical evaluation?
Above all, it is systematic proof that the medical device meets basic safety and performance requirements. The side effects that patients must expect and the consequences that can be ruled out are also documented in the clinical evaluation. It thus serves as evidence of a justifiable risk-benefit ratio.
A common misconception: Class I devices do not need a clinical evaluation. This is wrong, because every medical device is bound by the requirements of the MDR. Even if the Notified Body does not carry out a clinical evaluation test for Class I devices, an evaluation must still be available on request.
The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are mandatory documents of the technical documentation. They provide information on how manufacturers have proceeded in the preparation of the clinical evaluation.
The whole world of medicine: BAYOOMED @Medica 2021 
