Clinical Strategy as Part of Pre-submission Dialogue Between Manufacturer and Notified Body

In this Issue

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

From the Editor ✍🏽

On the heels of last week's European Association of Authorized Representatives in Brussels, my mind is on clinical strategy.

📌 Featured Post: A newly released joint position paper from MedTech Europe, AESGP, Medtech & Pharma Platform Association, and COCIR on the importance of clinical strategy in pre-submission dialogues with Notified Bodies was discussed by Natasha Bankowski.

🔥 Plus 14 more super-useful new posts, Martin King’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC.

✅ In honor of International Women's Day (IWD) on March 8, this Friday, MDG Premium will welcome guest speaker Margot Borgel, PhD, who will discuss current issues about "Women's Health in MedTech."

🐝🐝 Bonus: Be sure to follow the week-long LinkedIn series leading up to International Women’s Day on March 8 by Angelina Lisandrelli and Marina Daineko highlighting women’s health issues and the critical gaps in research and regulation that impact patient safety.

📌 Featured Webinar

Winning in the EU: Crafting a Bulletproof Clinical Strategy

EU MDR clinical approval isn’t just a requirement—it’s a make-or-break factor for your MedTech success. Yet, many manufacturers struggle with clinical evidence requirements, leading to delays, unexpected costs, and regulatory setbacks.

Join subject matter expert Lea Wettlauffer from the Johner Institute for a practical masterclass on crafting a bulletproof clinical strategy that accelerates EU approval. Learn the four essential success factors for an efficient, secure, and successful approach to MDR compliance.

📅 Tuesday, March 4, 2025 – 10 AM ET | 4 PM CET

📩 Recording & slides available for all registrants

Don’t miss this chance to refine your clinical strategy, save time, and reduce costs.Register now!

In Brief 💥

In no special order...

• Tibor Zechmeister provided an infographic with clinical evaluation advice for medical device compliance.
• EU MDR Compliance shared 20 recommendations for writing clear Instructions for Use (IFU) in medical devices.
• The European Commission published a draft amendment allowing electronic instructions for use (eIFU) for all medical devices used by healthcare professionals, shared by Stefano Bolletta.
• Marina Daineko shared news on calls for the EU to join MDSAP as a full member.
• Mexico establishes new minimum requirements for medical device design, development, and distribution, ensuring quality, safety, and performance, as highlighted by Mike B. W.
• 5 key do’s and don’ts for managing CAPA systems effectively in MedTech were outlined by Georg Digel.
• FDA reprocessing rules for single-use devices, was broken down by Dr. Pallavi Dasgupta.
• Yujan Shrestha, MD highlighted a potential $1M cost-saving method for AI/ML device ground truthing.
• MedBoard reported on the UK government’s response to consultation on medical device regulations, detailing changes in market access and in vitro diagnostics.
• Richard Holborow shared that the first expert panel scientific opinion in over two years has been published by the FDA.
• Key FDA cybersecurity principles for medical device software compliance were outlined by Jose Bohorquez.
• Corinne Carlucci-Mattle highlighted a new initiative to expand eIFU to a broader range of medical devices.
• BSI AI Regulatory Services provided a timeline for AI Act implementation in Europe.
• Martin King shared 10 new medical device industry standards in China.

Featured Post 📌

Postion Paper: Clinical Strategy as Part of Pre-submission Dialogue Between Manufacturer and Notified Body

This week, Natasha Bankowski shared a new position paper by MedTech Europe, AESGP, Medtech & Pharma Platform Association, and COCIR , which have raised serious concerns regarding the lack of clinical strategy discussions in the pre-submission phase between manufacturers and Notified Bodies. Despite updates to MDCG 2019-6 Rev. 5, the absence of structured clinical dialogue creates uncertainty, increases delays, and threatens device continuity—particularly for SMEs.

Why This Matters:

✅ Clinical strategy must be addressed early—manufacturers develop it months or years before MDR/IVDR conformity assessment applications.

✅ Pre-submission alignment with Notified Bodies improves dossier quality and reduces assessment timelines.

✅ SMEs face the biggest risk—limited financial and personnel resources make reworking applications or funding additional clinical data collection extremely difficult.

⚠️ Without early engagement on clinical expectations, device approvals will continue to face unnecessary obstacles, jeopardizing market access and innovation.

Read the full position paper.

Sections ✅

Regulatory Roundup by Martin King - Week of February 24, 2025

Featuring the latest regulatory updates from:📌 𝘊𝘦𝘯𝘵𝘳𝘢𝘭 𝘋𝘳𝘶𝘨𝘴 𝘚𝘵𝘢𝘯𝘥𝘢𝘳𝘥 𝘊𝘰𝘯𝘵𝘳𝘰𝘭 𝘖𝘳𝘨𝘢𝘯𝘪𝘻𝘢𝘵𝘪𝘰𝘯📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘊𝘰𝘮𝘮𝘪𝘴𝘴𝘪𝘰𝘯📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘋𝘢𝘵𝘢 𝘗𝘳𝘰𝘵𝘦𝘤𝘵𝘪𝘰𝘯 𝘉𝘰𝘢𝘳𝘥📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘏𝘦𝘢𝘭𝘵𝘩 𝘊𝘢𝘯𝘢𝘥𝘢📌 𝘏𝘦𝘢𝘭𝘵𝘩 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺 (𝘏𝘗𝘙𝘈) , 𝘐𝘳𝘦𝘭𝘢𝘯𝘥📌 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘢𝘯𝘥 𝘏𝘦𝘢𝘭𝘵𝘩𝘤𝘢𝘳𝘦 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘚𝘸𝘪𝘴𝘴𝘮𝘦𝘥𝘪𝘤📌 𝘛𝘩𝘦𝘳𝘢𝘱𝘦𝘶𝘵𝘪𝘤 𝘎𝘰𝘰𝘥𝘴 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 (𝘛𝘎𝘈), 𝘈𝘶𝘴𝘵𝘳𝘢𝘭𝘪𝘢📌 𝘜𝘚𝘈 𝘍𝘰𝘰𝘥 & 𝘋𝘳𝘶𝘨 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 𝘍𝘋𝘈

Powered by Hoodin.

✅ 510(k)s at a Glance for the week of February 24, 2025

Marcus Engineering, LLC highlighted 60 new FDA 510(k) cleared devices last week, including 18 first-time clearances. (🚀 indicates first-time clearances)

For full details, visit Marcus Engineering’s report.

🗓️ What’s Happening

• 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.
• NEW: March 12 and 19, "The Unspoken Rules of MedTech Success: Value, Market, Money" (a 2-part series featuring subject matter experts Edward Dougherty and Tatyana Staneva). Registration link coming soon!
• April 24-25, 2025, the 2nd International Conference on Medical Device Safety Risk Management, Amsterdam, The Netherlands. In-person and online registration.
• Plus, don't miss 10x2025 Humanizing Medtech, May 7-8, Newport Beach, CA.

Postscript 🐝

This week, I also shared the new issue of EU MDR & IVDR Insider, featuring the "EU Orphan Devices: A Clinical and Regulatory Playbook," by AKRA TEAM.

- Sean 🐝