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NAMSA Webinar: Current Opportunities and Challenges with Clinical Data Under EU MDR – A NAMSA Panel Discussion
May 6 @ 10:00 am - 11:00 am
Join BioOhio member NAMSA on May 6 for the webinar Current Opportunities and Challenges with Clinical Data Under EU MDR – A NAMSA Panel Discussion.
Join NAMSA’s Regulatory experts for this panel discussion to review current opportunities and challenges faced in the medical device industry today with the impending EU Medical Device Regulation (MDR) compliance deadline.
Topics to be covered during this webinar include:
- Sufficient clinical evidence – legacy vs new devices
- Post-Market Clinical Follow-Up (PMCF) support for MDR approvals
- Claims and clinical benefit
- Notified Body expectations
- Applicability of Article 61(10)
- Significant changes to devices during the Article 120 grace period
- High risk devices – the Article 54 process
Time for Q&A throughout the webinar will be available.