Clinical Data Under MDR: Understanding the Proposed Changes

MedTech Leading Voice | Issue 145

This week’s update focuses on proposed MDR amendments affecting clinical data requirements and clinical evaluation planning in 2026.

📝 From the Editor

Clinical data remains central to the evaluation of devices under MDR. This week’s featured article examines how the Commission’s proposed changes may influence regulatory strategy going forward.

🎯 Featured Article

Proposed MDR Amendments and Clinical Data Requirements

By Maria E. Donawa, M.D. — Donawa Lifescience

In this new article, Maria Donawa provides a structured examination of the European Commission’s proposed MDR amendments, with a specific focus on how clinical data requirements are being revised — and reinforced — across the regulation.

Rather than offering a high-level overview, the article works through the regulatory text itself, showing how changes to Articles, Recitals, definitions, and Annexes interact in practice. It is especially valuable for readers who need to understand how these proposals may affect clinical evaluation planning, equivalence strategies, and post-market obligations.

The article covers:

• How the proposed amendments modify — yet ultimately preserve — the blanket requirement for clinical data
• What revised wording in Article 61 means for demonstrating safety and performance
• Key Recitals shaping expectations for clinical evidence, equivalence, and PMCF
• Elimination of the standalone PMCF Evaluation Report and consolidation of documentation
• Changes affecting reliance on equivalent devices, including removal of contractual requirements
• Introduction of a formal definition for well-established technology devices and its regulatory implications
• Expanded eligibility for expert panel consultation across device classes
• Updates to scrutiny and consultation procedures for higher-risk devices
• Corrections to the definition of generic device group and why this matters for classification and grouping
• Revisions to the definition of clinical data and how equivalence is explicitly linked
• Amendments to Annex XIV affecting equivalence, PMCF justification, and documentation pathways
• Why unresolved clinical data expectations continue to impact market access decisions, particularly for smaller manufacturers

For regulatory, clinical, and quality leaders responsible for MDR compliance, this article offers a clear view of how the proposed changes fit together—and where uncertainty remains.

👉 Read the full article 

📌 This Week’s Top Posts (In no special order)

• Nazanin Sakhaei highlighted 10 critical capabilities that redefine the modern Regulatory Affairs Manager role.
• Key biocompatibility resources relied on during complex regulatory reviews were revealed by Marina Daineko.
• Angelina Lisandrelli summarized the MDCG guidances released in 2025 shaping EU medical device regulation.
• A Frontier AI Trends Report on evolving AI capabilities and risks, shared by Danny Van Roijen.
• Sigrid Berge van Rooijen underscored 5 critical barriers to AI success in the EHDS.
• The differences between ISO 10993-1:2018 and ISO 10993-1:2025 were detailed by Intrinsic Medical Group.
• Matrix One broke down the core frameworks guiding clinical validation and long-term reliability of MD-AI.
• The evolving impact of the AI Act on MDR and IVDR devices and resulting uncertainties were analyzed by MedQAIR.
• Michelle Lott clarified the difference between FDA clearance and real U.S. market adoption.
• Leonard Eisner outlined the December FDA Recognized Standards updates related to IEC 60601 and ASCA eligibility.
• Important regulatory responsibilities moving from MOHAP to EDE in the UAE were overviewed by Suhad AlNajjar.
• A personal journey and commitment to provide pro bono regulatory and quality support for paediatric device innovators was shared by Edwin Lindsay.

🗓️ Upcoming Events & Webinars

Friday In-Focus, January 9 | 11:00 am ET — IMDRF Initiatives 🏎️ Driving Global Regulatory Harmonisation with Stephanie Grassmann, exploring how IMDRF programs such as MDSAP, adverse event reporting codes, and reliance models are being implemented globally to support faster, more efficient market access across multiple jurisdictions. Registration coming soon >>

Thursday, January 22, 2026 | 10:00 AM ET / 4:00 PM CET —2026 Regulatory Roadmap: Key MDR & IVDR Compliance Prioritieswith Subject Matter Experts: Dr. Bassil Akra (AKRA Team), Erik Vollebregt (Axon Lawyers), Tom Patten (GMED) — A focused session on the milestones, pressures, and operational expectations shaping MDR and IVDR in 2026, including certificate renewal, PRRC oversight, clinical evidence pathways, and notified body interpretation trends. Register with one click >>

Wednesday, January 28, 2026 | 10:00 AM ET / 4:00 PM CET — Real-Life PMCF: Practical Lessons and 2026 Priorities, featuring subject matter experts Daniela Karrer and Matteo Mosso (Donawa Lifescience), with Diane Legere (DNV), focusing on how PMCF is applied in practice under MDR, including framing PMCF questions, selecting proportionate methods, and linking PMCF activities to CER updates and PSUR cycles, with reflections on current MDR revision work and notified body expectations. Registration coming soon >>

NEW 🔥 February 2–4, 2026 | Carlsbad, CA — Navigating Compliance for Medical Devices — Nemko & Eisner Safety Consultants - Three days of practical training on IEC 60601, EMC/RF, usability, software lifecycle, FDA/MDR expectations, and hands-on compliance workshops. Early-bird registration through December 31. Learn more >>

💥 Weekly 510(k) Roundup

December 29, 2025 | From Marcus Engineering, LLC

58 total clearances across multiple categories, including 13 first-time clearances (🚀)

• Pression, Inc. – Pression Wave PRO External Counter-Pulsation System (🚀): A non-invasive cardiovascular therapy system that uses synchronized lower-limb compression to support circulation for patients with angina and other cardiac conditions.
• Empatica S.R.L. – EmbraceMini Wearable: An ultra-compact, wrist-worn actigraphy device designed for continuous clinical-grade monitoring of sleep, activity, and physiological signals in real-world settings.
• UpDoc, Inc. – UpDoc Remote Patient Intervention Platform (🚀): A conversational AI–enabled virtual care platform that supports medication management, symptom tracking, and chronic disease monitoring through continuous patient engagement.

📋 Regulatory Roundup

December 29, 2025 Issue | By Martin King

This week’s regulatory activity reflects year-end positioning and early 2026 signals across medical devices, IVDs, medicines, and digital health.

Key developments:

• EU MDR/IVDR amendment proposals set the direction for simplification, transition clarity, and implementation realism
• Continued IVDR fragility and diagnostics access risks remain a concern across multiple regions
• Global regulators reinforce risk-based, lifecycle oversight with increased use of RWE and patient-preference data
• Notified Body capacity, transparency, and predictability remain active policy priorities
• AI governance, digitalisation, cybersecurity, and interoperability continue to mature as baseline expectations
• Supply resilience, shortages, and preparedness embedded more explicitly into regulatory frameworks
• Pharmacovigilance and safety systems expand in scope, data sources, and reporting expectations

Explore the Issue >>

✅ In Case You Missed It

Last week, I shared a snapshot of what we built together this year, and I want to pause here to thank everyone who has been part of it — the people who write, speak, join webinars, show up on Fridays, send notes, and share their work so openly.

This community grew because you contributed your time, your perspective, and your experience. What we published, covered, recorded, and learned this year reflects a shared effort, and I’m grateful for every person who helped shape it.

Thank you for reading, teaching, debating, and building alongside us.

Explore the Year in Review >>

🔥 Postscript

Catch all our MLV Webinar Replays and Friday In-Focus Calls on our YouTube Channels.

- Sean 🐝