Targeted Evaluation: EU Rules on Medical Devices and In Vitro Diagnostics

MedTech Leading Voice - Issue 99

Targeted Evaluation: EU Rules on Medical Devices and In Vitro Diagnostics

Sean Smith

Founder & Publisher | MedTech, Life Sciences, HealthTech | MDR/IVDR, QA/RA | Leading Voice Program | Worker 🐝

February 17, 2025

Click for Access to the New FREE Version.

In this Issue

From the Editor ✍🏽 | In Brief 💥 | What's Happening 🗓️ | Featured Post 📌 | Sections ✅ | Postscript 🐝

From the Editor ✍🏽

📌 Featured Article: Maria E. Donawa, M.D., makes a compelling case for MDR Clinical Data Mandate Threatening Device Access in Europe.

🔥 Plus 13 more super-useful new posts, Martin King’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC.

✅ In case you missed it, last Friday, Kevin Saem (Founder at Zapyrus) presented Finding the Right MedTech Opportunities at the Right Time on the free MDG Premium Zoom Call. Join us next Friday for Michelle Lott and Renae Franz (leanRAQA), who will discuss MedTech Commercialization Pitfalls.

Click to Register for FREE!

📌 Featured Webinar

Mastering Post-Market Surveillance: Avoiding Compliance Pitfalls & Misconceptions

Are you confident that your post-market surveillance (PMS), vigilance, and reporting processes align with the expectations of notified bodies?

Join subject matter experts Marta Carinelli (TÜV SÜD), Julia Hoyer (TÜV SÜD), Muna Kebede (AKRA TEAM), and Milad Masjedi (SGS Belgium) on Thursday, February 27, 2025, at 10:00 AM ET | 4:00 PM CET for an expert-led masterclass breaking down the most critical misconceptions about PMS under EU MDR and IVDR—and how to avoid compliance pitfalls.

You’ll gain insights directly from notified body experts on:

✅ The most common PMS misconceptions that lead to regulatory setbacks

✅ How notified bodies evaluate PMS, vigilance, and reporting compliance

✅ Best practices for streamlining post-market processes and staying audit-ready

Don’t risk compliance gaps or delays—register now to gain firsthand perspectives from industry experts. (Recording and slides provided to all registrants.)

In Brief 💥

In no special order...

Cécile van der Heijden explained the European Commission’s move to withdraw proposals for the AI Liability Directive and E-Privacy Regulation from its 2025 Work Program.

A comprehensive guide to market access for MedTech in Germany was shared by Stefano Bolletta, detailing key regulatory insights.

Thor Rollins explained how Extractables & Leachables (E&L) data can be used to evaluate sensitization risks in medical devices.

Why FMEA alone is not enough for medical devices was discussed by Beat Keller.

Danny Van Roijen highlighted a security assessment of medical wearables that revealed that none of the tested devices were free of cyber vulnerabilities.

PRRCs being the hidden champions of MDR manufacturers was discussed by Tibor Zechmeister.

J. David Giese noted that the number of De Novos granted each year has been steadily increasing.

A request for expert panel advice on clinical investigations under Article 61(2) of EU MDR was shared by Mike B. W..

BSI Medical Devices shared a document on UK capacity and lead times.

Dr. Sathesh Kumar Annamalai elaborated on IMDRF N81 guidance for strengthening software risk management in healthcare.

Fubin Wu explained why FDA delivers inconclusive responses, highlighting the complexity of regulatory decision-making.

🔥 Martin King announced Quality Management System Regulation QMSR 🎥 25 Minute The Final Cut: The Video Summary📄PDF Compendium Flipbook

Featured Article 📌

Click to Read Dr. Donawa's Article.

Maria E. Donawa Calls for MDR Revision to Address Clinical Data Challenges

In a February 14, 2025, comment on the European Commission’s public consultation on the revision of the EU Medical Device Regulation (MDR), Maria E. Donawa, MD, of Donawa Lifescience (Italy), submitted Comment 211, proposing a key revision to Article 61(1) to introduce greater flexibility in clinical data requirements.

In a related article, entitled MDR Clinical Data Mandate Threatening Device Access in Europe, Dr. Maria E. Donawa highlights the unintended consequences of the MDR’s "blanket clinical data requirement," emphasizing its impact on SMEs, regulatory burdens, and device availability in Europe. She argues that:

The rigid application of Article 61(1) forces manufacturers to generate clinical data for all devices, regardless of risk, with few exceptions, leading some to abandon the CE marking process entirely.

The previous Medical Devices Directives (MDD/AIMDD) allowed for more flexibility, recognizing that compliance with harmonized standards or preclinical data could sometimes suffice.

Article 61(10) exemptions, which could provide relief, are too rarely accepted, worsening regulatory inefficiencies.

This approach disproportionally contributes to medical device shortages, directly impacting patient access and innovation.

She proposes revising Article 61(1) to adopt a risk-based approach, ensuring clinical data is required only when scientifically justified, with alternative evidence such as preclinical or bench testing accepted where appropriate.

Readers are urged to submit comments to the European Parliament by 21 March 2025.

Sections ✅

Click to View the Regulatory Roundup.

Regulatory Roundup by Martin King - Week of February 3, 2025

Featuring the latest regulatory updates from: 📌 𝘊𝘰𝘧𝘦𝘱𝘳𝘪𝘴, 𝘔𝘦𝘹𝘪𝘤𝘰📌 𝘋𝘳𝘶𝘨 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺 𝘰𝘧 𝘗𝘢𝘬𝘪𝘴𝘵𝘢𝘯📌 𝘌𝘨𝘺𝘱𝘵𝘪𝘢𝘯 𝘋𝘳𝘶𝘨 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘊𝘰𝘮𝘮𝘪𝘴𝘴𝘪𝘰𝘯📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘏𝘦𝘢𝘭𝘵𝘩 𝘊𝘢𝘯𝘢𝘥𝘢📌 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘢𝘯𝘥 𝘏𝘦𝘢𝘭𝘵𝘩𝘤𝘢𝘳𝘦 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺 𝘔𝘢𝘭𝘢𝘺𝘴𝘪𝘢📌 𝘚𝘰𝘶𝘵𝘩 𝘈𝘧𝘳𝘪𝘤𝘢𝘯 𝘏𝘦𝘢𝘭𝘵𝘩 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺📌 𝘚𝘸𝘪𝘴𝘴𝘮𝘦𝘥𝘪𝘤📌 𝘛𝘩𝘦𝘳𝘢𝘱𝘦𝘶𝘵𝘪𝘤 𝘎𝘰𝘰𝘥𝘴 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 (𝘛𝘎𝘈), 𝘈𝘶𝘴𝘵𝘳𝘢𝘭𝘪𝘢📌 𝘜𝘚𝘈 𝘍𝘰𝘰𝘥 & 𝘋𝘳𝘶𝘨 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 𝘍𝘋𝘈

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✅ 510(k)s at a Glance for the week of February 3, 2025

Marcus Engineering, LLC highlighted 54 new FDA 510(k) cleared devices last week, including 10 first-time clearances. (🚀 indicates first-time clearances)

For full details, visit Marcus Engineering’s report.

🗓️ What’s Happening

Tuesday, February 25, Mastering FDA Cybersecurity Documentation for 510(k) Submissions: A MedTech Masterclass, featuring Jose Bohorquez and Mohamad Foustok of CyberMed

Thursday, February 27 - Critical Misconceptions About PMS, Vigilance & Reporting, featuring subject matter experts Marta Carnielli (TÜV SÜD) and Muna Kebede (AKRA TEAM).

Tuesday, March 4, Winning in the EU: Crafting a Bulletproof Clinical Strategy, featuring subject matter expert Lea Wettlauffer (Part 1 of a 3-Part Clinical Webinar Series with the Johner Institut GmbH.

Postscript 🐝

Will you join us in California for an all-new MedTech conference experience?

Message Me to Learn More!

It's not too late to register for The 9th EAAR Annual Conference on Medical Device Regulations in Brussels, Belgium -24-25 February 2025.

- Sean 🐝

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