Understanding Clinical Data under the MDR  

Collection of clinical data is a critical aspect of the conformity assessment process of medical devices. It serves to substantiate a manufacturer’s claim regarding the safety, performance and benefit/risk ratio of a given device. Clinical data is generally understood as evidence on the safety and performance of a medical device based on its actual usage and is typically derived from pre-clinical or clinical investigations, scientific literature and/or clinical experiences with similar devices. The EU Medical Device Regulation requires manufacturers to provide clinical evidence for all devices regardless of their classification, in the form of a clinical evaluation report (CER). The past practice of basing device safety and performance on competitive or comparative devices and providing written justification for waiving post-market clinical follow-up may no longer satisfy the requirements.

This webinar addresses the new requirements for clinical data under the Medical Device Regulation (EU 2017/745) and shares the findings of a Notified Body which has assessed the CERs of manufacturers of legacy devices previously CE-marked under the Medical Device Directive (93/42/EEC).

Date and time: Wednesday, 4 November 2020, 9:30 am (CET)

Your speaker: Robert Madjno, Director Clinical Assesment


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