Live! #63 – Start 2023 Right: Smart and Savvy Tips from Former Regulators and Notified Bodies

Device Advice by RQM+

This is audio from RQM+ Live! #63, recorded 26 January 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

The MedTech industry is one of the most heavily regulated industries in the world. The regulatory landscape is changing rapidly and regulations are increasingly more complex.
An efficient and scalable regulatory strategy is now more important than ever. As regulatory bodies worldwide update and enforce regulations at an accelerated pace, the need for speed and flexibility in regulatory functions has never been more critical. The alternatives are failed and damaging regulatory submissions that could ultimately stop a product from coming to market.
In this RQM Live! show, our panelists bring their unique perspectives on the world's largest regulatory markets, the US FDA and EU MDR/IVDR.
Our subject matter experts will:

• Discuss the greatest challenges in regulatory submissions to the FDA and notified bodies
• Provide advice on how to overcome these challenges
• Identify synergies and differences between EU and US regulators
• Provide top tips for successful product submissions and interaction with EU/US regulators

Panelists:

• Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
• Carlos Galamba, MSc – Vice President, Intelligence & Innovation - IVD
• Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation
• Jon Gimbel, Ph.D. - Vice President, Technical

Questions with timestamps:

4:22 -- So much has changed over the past few years. Let's discuss how much of a jump it's been for the European market compared to a few years ago and what that means for the FDA side?

9:40 -- What are the top five things that manufacturers underestimate about these regulatory requirements?

10:34 -- How do you go about gathering and presenting documentation for an MDR compliant submission when your notified body won't communicate their criteria and refuses to offer guidance because they're not consultants?

24:20 -- Considering the differences between the EU and the US, what about some of the synergies between the two?

33:18 -- What updates or advice do you have on the timeline extension on the MDR and IVDR?

37:05 -- Are they extending the MDD certifications?

41:48 -- If our MDD certificate expiries in March 2024, wouldn't it need a new date at that point to sell from that day until the MDR certification is obtained? It could take two years until that point...

45:40 -- In relation to the MDD/MDR transition period, for elements like standards, where there may be a difference between the MDD harmonized version and the MDR harmonized version, how should manufacturers handle compliance to older versions for MDD when we are trying to transition to the State of the Art harmonized versions for MDR.

49:02 -- There seems to be a strong incentive to not be novel. Do you see companies underplaying novelty and is there a risk to this?

53:21 -- The end of life of our device that is no longer manufactured is planned for 2027 or 2028. Do we have to pursue MDR certification?

54:55 -- What is your experience with the use of off-label data (while supporting the safety and performance of a medical device) for CE-mark?

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