Clinical Evaluation Under the MDR With and Without Clinical Data

On 25th May 2017, the new EU Medical Device Regulation (MDR) entered into force and will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). While the ideology of evaluating clinical evidence to demonstrate compliance with relevant General Safety and Performance Requirements remains unchanged, the MDR along with the recently published MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence and MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices includes stringent requirements for acceptable clinical data, demonstrating equivalence to a marketed device, and the ability to establish conformity for devices in which clinical data is not deemed necessary (Article 61 section 10).

This session will provide practical examples of devices that meet Article 61(10) requirements, class I devices that require clinical data and the proper methodology for establishing equivalence under the MDR. This session will also provide recommendations on how to use the delay on the date of application of the MDR to initiate clinical data collection for submission.