Good AI Practice: Mapping EMA–FDA Alignment With IMDRF, OECD, and WHO

MedTech Leading Voice | Issue 147

Good AI Practice Takes Shape: What EMA–FDA Alignment Signals for 2026

This week’s update highlights new global guidance on good AI practice across the medicines and devices lifecycle, alongside field notes on ISO 10993-1:2025, early-stage regulatory strategy, cybersecurity expectations, and operational signals shaping 2026.

📝 From the Editor

A new piece from Martin King outlines the emerging alignment between EMA, FDA, IMDRF, OECD, and WHO on lifecycle-based AI governance.

The principles highlight documentation, traceability, and operational control as the foundation for safe and reliable AI use in regulated health settings.

This week’s featured post explores that convergence and what it means for teams planning 2026 portfolios.

— Sean Smith, Publisher

🎯 Featured Post

Good AI Practice for 2026: How EMA–FDA Guidance Is Converging With Global Frameworks

The EMA–FDA joint statement on 10 guiding principles for good AI practice marks a step toward shared expectations for how AI systems should be developed, validated, and monitored across medicines and medical devices.

In his latest article, Martin King maps these principles against IMDRF, OECD, and WHO frameworks, highlighting areas where global bodies are now reinforcing similar foundational requirements:

• Transparency and documentation — Teams must be able to explain data sources, assumptions, model behavior, intended use, and change history.
• Lifecycle oversight — Continuous monitoring, robustness checks, and drift evaluation are treated as core obligations, not optional enhancements.
• Human accountability — Clear ownership, well-defined decision pathways, and structured safeguards remain essential, even in highly automated systems.
• Evidence quality — Validation must reflect clinical context, real-world conditions, and measurable performance over time.

Martin notes that this convergence points toward more uniform expectations in 2026. Teams building or integrating AI will face stronger scrutiny of documentation discipline, risk management alignment, and operational readiness. View the post >>

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

• Key ISO 10993-1:2025 field notes emphasizing chemical characterization as the true starting point for biological risk, by MedCore by Marina Daineko.
• Angelina Lisandrelli compiled a list of important CFRs to build regulatory credibility beyond 510(k) experience.
• Leo Eisner shared a standards update on the cancellation of IEC TR 60601-4-9 and the release of three IEC 60601-1 4th Edition fragments for public comment, outlining upcoming work on user-interface aspects, materials hazards, and optical radiation.
• An article on modernizing ISO 14971 risk management with database-driven FMEAs was written by Manfred Maiers.
• Sigrid Berge van Rooijen curated a list of 2026 healthcare innovation conferences across Europe and the Middle East.
• A recent white paper on early-stage regulatory planning for medtech startups was shared by Stefano Bolletta.
• Matrix One broke down key EU eIFU requirements under the 2025/1234 regulation for compliant implementation.
• Michelle Lott revealed the FDA’s intent to tighten product positioning evaluations, signaled by a surge in recent warning letters.
• The value of Gemba Walks for uncovering process issues and strengthening quality culture was highlighted by Bastian Krapinger-Ruether. 
• Jose Bohorquez underlined the medical device post-market cybersecurity process for monitoring, assessing, and responding to vulnerabilities.
• A continuous, risk-based approach to medical device FTO was underscored in an article by Eunice Baker White.
• Shaherah Yancy discussed the true definition of FDA Breakthrough Device Designation, in a helpful video. 
• An FDA update to the General Wellness policy for low-risk devices was summarized by Bryce Whitehead.
• Tamiko Eto detailed red flags for IRBs when AI tools cross into screening, prediction, or clinical decision-making.
• Danny Van Roijen explained the European Commission’s Q1 2026 road ahead, on upcoming proposals and consultation deadlines. 
• EMA and FDA’s 10 guiding principles for good AI practice across the medicines lifecycle were summarized by the European Medicines Agency.
• Martin King defined the FDA–EMA AI guiding principles in his latest article, mapping alignment with IMDRF, OECD, and WHO.

🗓️ 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 >>

Friday In-Focus, January 23, 2026 | 11:00 AM ET — Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026, featuring Beat Keller (SMDC), focusing on how IEC standards become EN harmonized standards for MDR/IVDR, the role of Z-Annexes in mapping requirements to GSPRs, and what engineering and RA/QA teams should anticipate for 2026. 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. Register Now >>

🔥 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. Discount code MLV15 for 15% off. Learn more >>

💥 Weekly 510(k) Roundup

January 12, 2026 | From Marcus Engineering, LLC

60 total clearances across multiple categories, including 12 first-time clearances (🚀)

• RemSleep Holdings, Inc. — DeltaWave Nasal Pillow System: A new nasal pillow design cleared for sleep therapy, focusing on comfort, reduced noise, and improved patient usability for positive-airway-pressure treatment.
• GI Windows Surgical, Inc. — Self-Forming Magnet (Flexagon Plus OTOLoc): A magnet-based tissue apposition system cleared for internal closure applications. Precision-engineered magnets create consistent approximation without sutures or staples.
• iotaMotion — iotaSOFT® Insertion System: A robotic-assisted cochlear implant insertion tool cleared to support controlled, slow advancement of the electrode array while maintaining surgeon command.

Explore the full list of this week’s clearances on the 510(k) Roundup page.

📋 Regulatory Roundup

January 12, 2026 Issue | By Martin King

This week’s regulatory activity highlights the developments shaping medical devices, IVDs, pharmaceuticals, digital health, and GMP/GDP across Asia-Pacific, Europe, the UK, the US, and Switzerland.

Key developments:

• New oncology medical device risk classifications (India)
• EMA COMBO developments for combination products
• FDA clarity on Clinical Decision Support software and General Wellness devices
• Strengthened MAH accountability in outsourced manufacturing (China)
• Updated clinical investigation rules and fees (UK)

Explore the Issue >>

In Case You Missed It

Wednesday, January 14, 2026 | 10:00 AM ET / 4:00 PM CET — MedTechUX: Conquering the Human, featuring Merrill Zavod, PhD, Associate Director of User Experience at ClariMed, Inc., exploring how human-centered design, behavioral insight, and usability strategy influence real-world device adoption, safety, and regulatory outcomes across the product lifecycle. Watch the replay here >>