The Medical Device Regulation (MDR) is fully applicable in the EU since 26 May 2021. The timelines for ensuring your product achieves or maintains EU market access under the new, more stringent MDR are challenging. Our webinar will provide you with useful information around the routes to conformity for personalized medical devices under the MDR.
Who should attend the webinar?
This webinar will be useful to manufacturers of personalized medical devices and anyone with an interest in the regulatory paths for personalised medical devices. Also, anyone who is involved with classification of personalized medical devices, will also find this webinar insightful.
What will participants gain?
Join Dr Tim Marriott, Senior Technical Specialist and Scheme Manager, BSI, to hear about important insights into routes to conformity for personalized medical devices. Tim will also be joined by Judith Prevoo, Regulatory Lead, BSI. Participants will gain an understanding of the regulatory requirements for personalized medical devices as well as an explanation of common pitfalls of classifying personalized devices.