NAMSA invites you to join us for this unique opportunity to learn direct from the industry’s foremost leading medical device regulatory experts. Our panel of experts is comprised of former Notified Body managers and seasoned medical writing professionals with hands-on industry experience with EU MDR clinical data and associated requirements.
This webinar will provide a detailed discussion on the challenges and opportunities manufacturers will face as a result of the enhanced MDR clinical requirements, including the recent, proposed implementation delay of MDR.
Additional 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