Orphaned Devices - The Needs, Approval Process and Challenges in the EU

Description: Over the last years, clinical experts in hospitals have been expressing their concerns on the availability of devices for specific patient populations and uses as a result of the requirements in the EU MDR. The needs for these devices are imminent, and this has resulted in the publication of MDCG 2024-10.
In a moderated session, Tom Melvin will present on the need for market access of orphaned devices and provide examples of devices identified to be in scope.
Since the publication of the MDCG guidance 2024-10, manufacturers and regulators have been working on this process and the intent towards CE marking. Richard Holborrow will present the experiences from a Notified Body perspective: what are points to consider and ask of your notified body in relation to ensuring your application is successful. This could include how to prepare a CER, justification and how to relay the advice of the expert panels to the NB.
Nona Heueis will share experiences on the process towards CE marking from manufacturer point of view – determination of Orphaned device status – communications to NB and expert panel – tips/tricks.
Does this guidance cover all situations? is the Orphaned device definition sufficient? A comprehensive overview of additional activities being worked on / recently published is presented by Leo Hovestadt.
Through a moderated panel discussion, the latest experiences from these panelists will be presented.