A New Phase of MDR/IVDR Reform Begins — Plus this week’s highlights and a standout webinar replay

MedTech Leading Voice | Issue 143

Manufacturers received long-awaited clarity this week as the European Commission released its proposal to streamline MDR/IVDR and address persistent system strain.

📝 From the Editor

The European Commission’s new proposal introduces targeted adjustments to the MDR and IVDR, giving manufacturers and notified bodies a clearer basis as they plan for the year ahead. The proposed changes touch certification, clinical expectations, PRRC responsibilities, and the mechanics of regulatory submissions.

We also hosted one of our largest sessions to date this past week, bringing together more than a thousand professionals for a detailed walkthrough of the evolving regulatory landscape. This issue includes a recap and the replay link for anyone who missed it live.

— Sean Smith, Founder & Publisher

🎯 Featured Post

The European Commission Outlines Key Adjustments to MDR/IVDR for 2026

Mario Gabrielli Cossellu reviewed the European Commission’s newly released proposal to streamlinethe MDR and IVDR, which introduces targeted changes to ease system pressure and improve predictability for manufacturers and notified bodies. The proposal focuses on administrative burden, certificate management, clinical expectations, and regulatory pathways that will guide 2026 planning.

He highlighted several areas that teams should track closely:

• A more structured approach to certificate renewal and validity
• Adjustments to PRRC responsibilities and oversight expectations
• Updated provisions meant to support notified body capacity
• Clearer clinical-evidence pathways aligned with device type and risk
• Digital submission and documentation efficiencies designed to reduce review friction

His summary emphasizes that the proposal represents a meaningful signal from regulators as organizations prepare for a heavier compliance cycle in 2026. View the post >>

🎥 Featured Webinar Recap

MDR/IVDR in Transition — Our Most Attended Session Yet

Last week’s session on the evolving MDR/IVDR landscape brought together more than 1,245 registrants and over 500 live attendees, marking one of our largest events to date. The discussion focused on the regulatory pressures shaping 2026, extended transition expectations, notified body capacity, and the areas where requirements are tightening.

Subject Matter Experts: Alex Laan, Head of the Notified Body, BSI; Philippe Auclair, Senior Consultant, AKRA TEAM; Tirion Evans, Head of Notified Body & Approved Body, Scarlet provided clear, practical insight into what manufacturers should prepare for as the Commission advances its proposal and notified body interpretation continues to shift.

The full replay is now available for anyone who couldn’t join live. Watch the replay >>

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

• Danny Van Roijen reviewed the World Economic Forum’s report on quantum technologies and their emerging role in healthcare.
• The European Commission’s proposal to simplify and streamline medical device regulations was summarized by Mario Gabrielli Cossellu.
• The UK MHRA’s newly published IVD Medical Device Roadmap and its 2026–2027 regulatory priorities were announced by MedBoard.
• Manfred Maiers discussed the foundation of compliant, connected AI in manufacturing and CAPA in his latest article.
• 14 ways AI can improve diagnostics across imaging, pathology, and triage were outlined by Sigrid Berge van Rooijen.
• An FDA guidance on enhancing participation in clinical trials was underscored by Stefano Bolletta.
• Intrinsic Medical Group revealed key terminology and terms changes introduced in ISO 10993-1:2025.
• In her weekly Monday news, Marina Daineko shared updates on FDA QMSR readiness, global regulations, and MedTech leadership.
• EU MDR Compliance overviewed the importance of SRS documentation in building traceable, audit-ready SaMD.
• Best practices for using a layered design freeze as a risk-control tool were highlighted by Matrix One.
• A recent EU Commission proposal on MDR and IVDR changes was broken down by Tibor Zechmeister.
• Beat Keller clarified the difference between air clearance vs creepage distance and their role in IEC 60601-1 safety requirements.
• Bastian Krapinger-Ruether noted the strategic role of PSURs in protecting devices on the EU market, turning compliance into an advantage.
• Key regulatory shifts affecting SaMD and AI-enabled medical devices under the EU Commission’s proposal were detailed by Leon Doorn.

🗓️ Upcoming Events & Webinars

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 >>

No Friday In-Focus on December 27 — There will be no FIF call this week as the team takes a short year-end break.

Friday In-Focus Returns January 2 — We restart the weekly series on January 2 with a Year-in-Preview session led by Sean Smith, an overview of the regulatory, commercial, and visibility themes that will shape early 2026 for MedTech consultants and manufacturers. 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 15, 2025 | From Marcus Engineering, LLC

50 total clearancesacross multiple categories, including10 first-time clearances (🚀)

• BrightHeart – Fetal EchoScan: An AI-enabled fetal echocardiography tool that supports clinicians by capturing high-quality cardiac views during prenatal scans and flagging potential congenital abnormalities.
• Cresilon, Inc.– TRAUMAGEL® 2.0 Hemostatic Gel: A rapidly applied, plant-based hemostatic gel designed for emergency care, trauma settings, and field use, providing fast support in managing bleeding without preparation time.
• Ceribell – Delirium Monitor System: A point-of-care EEG system using AI-enabled continuous monitoring to detect signs of delirium in critically ill patients, improving clinical visibility and early response.

📋 Regulatory Roundup

December 15, 2025 Issue | By Martin King

This week’s regulatory activity highlights convergence around AI controls, lifecycle evidence expectations, accelerated pathways, and reinforced manufacturing oversight.

Key developments:

• AI, Data & Digital (EMA, CIOMS, European Commission, ISO)
• Evidence & Development (EU HTA / EMA / EU-IN)
• Approval Pathways & Timelines (EU / UK / International)
• Manufacturing, Quality & Supply (EMA, EDQM, Council of Europe, EDA, Swissmedic)
• Devices & Diagnostics (CDSCO, Spain Ministerio de Sanidad, EU HTA)
• Incentives & Market Access (ANVISA Brazil, Egypt, EU)
• Explore the Issue >>

In Case You Missed It

How to Become a Lead Auditor for Software as a Medical Device — Masterclass | Wednesday, December 17, 2025 | 3:00 PM ET | With Subject Matter Expert: Rob Packard, President, Medical Device Academy - A practical walkthrough of SaMD audit leadership, audit planning, key QMSR changes, and tools that support audit-ready software processes. Watch the replay >>