Clinical Evaluation of Medical Devices and the Consequences of the MDR for this Process

This presentation will discuss the clinical evaluation requirements laid down in the new MDR and their implications for medical devices manufacturers. The presentation will include discussion concerning the conditions which must be met by manufacturers to be able to rely on clinical data related to a medical device for which they claim equivalence with their own product. Elisabethann and Fabien will also discuss the implications of the EU General Data Protection Regulation (GDPR) which will be applicable from 25 May 2018 for the clinical evaluation of medical devices.