WET Expansion and Article 61(10) Redefine Clinical Evidence Pathways

MedTech Leading Voice | Issue 157

Clinical Evidence Strategy in Transition

📝 From the Editor

This week’s issue centers on clinical evidence — and the growing precision regulators are bringing to how it is justified, structured, and defended.

Across discussions on WET expansion, Article 61(10), AI oversight, evolving standards, and digital reporting infrastructure, one pattern stands out: evidence strategy is becoming more integrated with risk management, software governance, and lifecycle monitoring.

The 15 posts below reflect that shift. Each contribution comes from experts working directly inside these frameworks — clarifying where expectations are tightening and where strategy must follow.

— Sean Smith

🧠 Clinical Evidence & EU MDR Strategy

WET Expansion and Article 61(10) Redefine Clinical Evidence Pathways

Recent updates to the MDR framework highlight how expectations for clinical evidence are evolving across the EU. Mariarosaria Sollo examined the European Commission’s expansion of Well-Established Technology (WET) exemptions for certain implantable and Class III devices, while Firas Alani clarified the structured application of Article 61(10) when non-clinical data may replace clinical evidence. Together, these developments signal a more deliberate and risk-based approach to clinical strategy, requiring manufacturers to align technical documentation, risk management outputs, and conformity assessment pathways with clearly justified evidence frameworks.

🤖 AI Governance & Regulatory Direction

AI Act Implementation and FDA Alignment Shape Oversight Expectations

AI governance continues to take shape across global regulatory systems. Stefano Bolletta highlighted newly adopted EU Parliament texts aimed at simplifying AI Act implementation while reinforcing safety oversight, and Nina Kottler clarified FDA terminology distinctions across AI-enabled medical device pathways. Complementing these updates, Sarah Moeller outlined the 10 FDA–EMA guiding principles for AI in drug and biologics development, reinforcing the importance of lifecycle governance, transparency, and risk-based validation as AI technologies move deeper into regulated healthcare environments.

📚 Regulatory Learning & Standards Development

Standards, Risk Models, and Evidence Frameworks Continue to Evolve

This week’s learning-focused posts addressed foundational elements shaping regulatory practice. Tibor Zechmeister summarized updates to ISO 10993-12 that affect extraction methodologies and biocompatibility testing justification, while Leo Eisner explored the integration of ISO 20417:2026 into the IEC 60601-1 safety architecture. Ramin Parchetalab revisited software risk probability assumptions under IEC 62304 and ISO 14971, emphasizing the distinction between defect occurrence and patient harm. Collectively, these insights reinforce the increasing technical rigor required in standards alignment, documentation integrity, and risk-based regulatory decision-making.

Also, EU MDR Compliance underscored the role of Basic UDI-DI, UDI-DI, and UDI-PI in enabling device identification and traceability within regulatory systems. And, Beat Keller highlighted the cause of instability findings under IEC 60601-1 Clause 9, noting how reliance on ideal configurations can lead to non-compliance observations.

🌍 Regulatory Systems, Data & Market Dynamics

Digital Infrastructure, Safety Science, and Policy Evolution Advance Global Oversight

Additional contributions highlighted broader structural shifts across the MedTech landscape. Intrinsic Medical Group examined the EU roadmap toward animal-free chemical safety and its implications for medical devices, while Jose Bohorquez discussed findings from a Stanford study on AI-assisted coding and software security risk. Marina Daineko provided her weekly overview of regulatory updates, recalls, and approvals, and Markus Pöttker reported on updates to the EU Manufacturer Incident Report (MIR) form. Together, these developments reflect ongoing convergence across data governance, digital infrastructure, and lifecycle regulatory oversight.

🗓️ Upcoming Events

• April 3, 2026 | 11:00 AM ET - Regulatory Intelligence Is Only the Start: Managing Impact, Standards, and Submission Work in One Flow, Featuring Priya Bhutani, RegDesk
• April 10, 2026 | 11:00 AM ET - PMCF Surveys Under MDR: When They Apply, How to Structure Them, and What Good Looks Like, Featuring Marcus Torr, Purdie Pascoe
• April 17, 2026 | 11:00 AM ET - Global Regulatory Submissions Made Simple – Leveraging AI and Existing Market Approvals, Featuring Oliver Eikenberg, Pure Global
• April 24, 2026 | 11:00 AM ET - AI/ML FDA Submissions: Common Pitfalls, Hard Lessons, and Faster Paths Forward, Featuring Leon Doorn

💥 Weekly 510(k) Roundup

March 23, 2026 | From Marcus Engineering, LLC

75 total clearances this week across all device categories, including 13 first-time clearances (🚀)

Featured clearances:

• LimFlow (now part of Stryker) — LimFlow Vector: A system for severe peripheral artery disease that reroutes arterial blood into the venous system to restore lower limb circulation.
• Cala Health — Cala kIQ Plus: A wrist-worn neuromodulation device delivering personalized electrical stimulation to reduce essential tremor during daily activities.
• Nexstim — Navigated Brain Stimulation (NBS) 6 System: A navigated transcranial magnetic stimulation platform integrating MRI data to map functional brain regions for pre-surgical planning.

📋 Regulatory Roundup

March 23, 2026 | By Martin King

Regulators across the FDA, EMA, MHRA, TGA, HSA, MDA, Swissmedic, and other authorities continue advancing lifecycle-based oversight models built on digital infrastructure, reliance pathways, and data-driven surveillance. This week’s updates reinforce expanding AI integration, strengthened post-market safety communication, cybersecurity governance within regulatory scope, and coordinated global alignment, shaping access and compliance strategies. Explore the update >>

🔥 Postscript

Connected Device Cyber Resilience Resources

Last week, nearly 400 professionals joined the recent Connected Device Oversight Assessment Workshop. Mark Omo’sCONNECTED DEVICE GOVERNANCE QUICK START GUIDE - A Practical Oversight Assessment for Regulatory and Quality Teams

30 Governance QuestionsEvery Regulatory and Quality Team Should Be Able to Answer

Sean 🐝