No Easy Answers: EU MedTech Innovation

In this Issue

From the Editor ????| In-Brief?? |?Featured ???| Sections ? | Postscript ??

From the Editor????

In this issue, I shared some of my reflections about the 8th EAAR Annual Conference on the Medical Device Regulations in Brussels, Belgium, last week and the question of balancing regulation, patient safety, and innovation in the EU.

?? Plus, 13 super-useful new posts and Martin King Martin King 's Regulatory Roundup

? Reminder

Join us this week for QMSR Masterclass: What You Need to Know , featuring experts Michelle Lott, RAC , Principal and Founder of leanRAQA, and àngel Buendía ?? from Scilife .

In Brief ??

• FDA eSTAR Survey: Graduate student Krishna Patel wants your help with a survey about the enhancement of the FDA eSTAR program . Please contribute your insights.
• The Interaction between the proposed AI Act MDR and IVDR was detailed in a post by Alex Denoon
• Qserve Group shared a thoughtful blog on the role of AI in the EU and its progression to fostering innovation?
• Explanation on obtaining a CE Mark and meeting ISO 13485 compliance for a new Class II device was underscored by Parul Chansoria?
• The NIST Cybersecurity Framework 2.0 document was underscored by Eric Henry?
• Marina Daineko explained the most frequent trap related to biocompatibility ??
• Process validation requirement procedure template was shared in a helpful post by Brian Newbery?
• The diverse skills needed during a medical device design project were explained by EU MDR Compliance
• Stefano Bolletta highlighted Australia’s latest guidance on medical device labeling obligations?
• Mike Wetherington shared recent FDA news on fraudulent and unreliable laboratory testing data?
• Joe Byrne shared a list of the top required contents needed for 510(k) submissions?
• Policies, programs, and statements relating to Compliance used by FDA personnel were detailed by Rohit Yadav?
• Intrinsic Medical Group outlined interesting topics discussed during the last FDA medical device sterilization town hall?

Featured ??

No Easy Answers: EU MedTech Innovation

Balancing Regulation, Safety, and Innovation (Part 1 of 2)

How can I possibly summarize two full days of expert presentations and discussions with key MedTech stakeholders, including competent authorities, notified bodies, veteran consultants, and manufacturers alike?

I cannot possibly do it justice.

Instead, I will attempt to share my impressions from both days of the 8th EAAR Annual Conference on the Medical Device Regulations in Brussels, Belgium.

In his opening remarks, Conference Chair Ludger M?ller struck a chord that was echoed by various speakers throughout the conference, expressing concerns about the application of the Medical Device Regulation (MDR) to legacy products, highlighting the challenges of aligning pre-existing clinical data with new MDR requirements.

He noted that while MDR benefits new and complex products, it imposes significant scrutiny without materially impacting the design or manufacturing of existing products. For lower-risk products, the MDR's clinical data requirements are seen as particularly burdensome, suggesting a need for ongoing discussion to find solutions.

MDR/IVDR State of Play and Next Steps

In session one, Flora Giorgio , Head of Unit, D3 for Health and Food Safety (DG SANTE) at the European Commission, Belgium, reported on the progress of the MDR/IVDR transition, discussing key milestones and acknowledging some remaining challenges.

Merlin Rietschel, Senior Manager of Medical Devices with MedTech Europe, representing the industry point of view while acknowledging the progress, was somewhat more critical. As he said:

But what we need now is to take a step back and have a look at what's going wrong with the MDR and perform a root cause analysis, and, based on that, suggest profound structural changes.?

EU MS Variations Despite MDR/IVDR

Session two focused on regulatory variations in Belgium, Germany, Spain, and the Netherlands, featuring enlightening presentations by Alexandre Jauniaux , Ludger M?ller , Claire M. Murphy , and Annette Van Raamsdonk .

Technical Documentation, Clinical Expectations, and Q&A

During session three, Marta Carnielli , Milad Masjedi , Anna Pietersma, Ph.D., and Francoise Schlemmer shared the notified expectations. Several underscored the additional capacity and extensions, encouraging manufacturers not to delay their applications until the minute.

Positive and Negative Experience with EU Notified Bodies

Bassil Akra , CEO and Owner of Akra Team, Germany, shared a number of real-life examples, positive and negative, with notified bodies. With regard to the notified body certification process, however, he pulled no punches, asking the audience directly:

How many of you see negative experiences with applications to notified bodies? I assume a lot of you will see negative experiences. Why? Because the system is still old-fashioned.

In the end, he reminded the audience of the spirit of MDR/IVDR--patient safety--encouraging everyone to remain focused on that objective.

Digital Era & Medical Devices

• Sarah Panten shared her vision for how technology, specifically digitization of Technical Documentation, promises the transform the regulatory process from end to end.
• On the legal front, Erik Vollebregt brought clarity to the legalities of AI in MedTech. He emphasized, among other things, the critical need for valid clinical evidence when it comes to Software as a Medical Device (SaMD).
• Koen Cobbaert from Philips took the stage to discuss the AI Act, detailing where AI fits within the current regulatory framework for MedTech. His practical examples provided a clear view of what's possible now and what we might expect in the future.

Manufacturer's Success Story in Implementing MDR

Rounding out the day, Leo Hovestadt , Director of Governmental Affairs EU, ELEKTA | Nucletron, Netherlands, shared his views on the regulatory process, clinical data, and the AI Act.

Last but not least, Antoine Beis , Projects Director & Certification Officer, EMD Technologies, Canada, shared in detail his first-hand, sometimes trying, experience as an SME going through the MDR approval process.

Special thanks to Ajda Mihel?i? for inviting me to attend.

I'm already looking forward next year!

Sections ?

??Weekly Regulatory Roundup

By Martin King , February 26, 2024

In This Week's Regulatory Roundup

?? New Updates from?the Active Pharmaceutical Ingredients Committee (APIC), CDSCO (India), Egyptian Drug Authority, European Commission, European Medicines Agency, International Council for Harmonization, Medical Device Regulators Authority Malaysia, Medicines and Healthcare Products Regulatory Agency (UK), MEDSAFE New Zealand, Swissmedic, Therapeutic Goods Administration (TGA), Australia, US FDA, Team AB (UK), and US FDA.

Postscript ??

PS - Coming Wed., Feb 13, A new MedTech Cybersecurity Webinar with Leon Doorn .

Stay tuned for more exciting events coming soon...

Sean ??