What is clinical evaluation under MDR ? скачать в хорошем качестве

What is clinical evaluation under MDR ?

The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark. In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD. Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the changes in clinical evaluation under the MDR. In this webinar, we will review the requirements for clinical evaluation and the best practices to address these changes effectively