Clinical Challenges under the EU MDR
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With the EU Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the MDR, and introducing new products. Although the Medical Device Coordination Group (MDCG) guidance has been forthcoming, there remain significant gaps in guidance and interpretation of requirements, and varying interpretations of expectations. In addition with the limited number of Notified Bodies designated under the MDR, there is substantial pressure to make MDR submissions as soon as possible to avoid the “cliff edge” of May 2024.
A few examples of the clinical and regulatory challenges include:
- Strategies for Post-Market Clinical Follow-up (PMCF) and implementation of those activities
- New clinical investigation submissions
- Presentation of clinical data within the MDCG and MEDDEV framework.
NAMSA invites you to view this webinar as our team of regulatory experts discuss practical insights to address these challenges.
Attendees can expect to gain a better understanding of:
- Increased clinical data requirements under the EU MDR, particularly in relation to PMCF
- How to define and plan appropriate strategies to meet requirements under the EU MDR
- NAMSA experiences with multiple manufacturers and Notified Bodies
- Challenges faced by other manufacturers and proposed solutions
- Carefully planned MDR submissions
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