Introducing ISO/IEC TS 42119-2:2025: The First AI Testing Standard Lands

MLV Issue 137 — New Formal Guidance for Testing AI Systems

Your weekly source for medical device regulatory intelligence

📝 From the Editor

Artificial intelligence is becoming part of the regulatory foundation of MedTech.

The new ISO/IEC TS 42119-2:2025 introduces formal guidance for testing AI systems and applies risk-based verification principles to product development. It provides structure where most teams have relied on interpretation, setting the groundwork for predictable and auditable AI validation.

This week’s updates highlight growing alignment across standards and regulators, from advancements in IEC 60601-1 to MDR implementation efforts worldwide.

🎯 Featured Webinar: Building a MedTech Market Pathway — November 12 at 11 AM ET with Michelle Lott, Fernanda Nusbaum, and Renae Franz. Register Here →

📥 How to Initiate Pre-Market Clinical Trials (In Just 5 Minutes a Day)

Free Step-by-step lessons on initiating first-in-human and pre-market device studies. Register now and share with your team this week.

📚 Featured Post

The First AI Testing Standard Has Arrived

Michael Galliker shared that the first official AI testing standard — ISO/IEC TS 42119-2:2025 has been published, marking a milestone in regulated AI validation.

This new technical specification extends the ISO/IEC/IEEE 29119 series into AI systems, establishing a risk-based approach to testing that integrates safety, reliability, and bias management.

For MedTech teams building or assessing AI-enabled devices, it provides the first shared framework for evaluating algorithmic performance and assurance.

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

• Mike B. Wetherington emphasized the importance of early FDA feedback in shaping a startup’s regulatory strategy and demonstrating system maturity.
• An upcoming podcast discussing the new ISO 10993-1 revision and its transition timing was announced by Marina Daineko.
• Michael Galliker shared the release of the first AI testing standard, ISO/IEC TS 42119-2:2025, introducing risk-based testing guidance for AI systems.
• The latest EMD Mag explores the role and fit of the Notified Body model in today’s MedTech landscape, as outlined by Monir El Azzouzi. 
• Leonard Eisner underscored key updates from Milan’s IEC TC62 meetings, noting progress on the IEC 60601-1 4th Edition. 
• Blue Goat Cyber noted the FDA’s increased focus on cybersecurity safety and compliance under Section 524B.
• A helpful risk classification cheat sheet comparing FDA and MDR device classifications, underlined by Tibor Zechmeister.
• Sharath Chandra Bhat detailed an article on test method validation for medical devices, covering hardware–software differences and regulatory requirements.
• The hierarchy of clinical evidence under EU MDR Annex X was illustrated by Dr. Pallavi Dasgupta.
• Yujan Shrestha summarized key 2024 CLAIM checklist updates, on FDA-aligned terms, data separation, and reference standard justification for AI/ML imaging.
• In a recent episode, Michelle Lott covered how to build a strong 510(k) submission, highlighting it as the cornerstone of a device’s market credibility.
• Bastian Krapinger-Ruether highlighted a useful PMS cheat sheet to proactively monitor risk and compliance. 
• Sydney Rodrigues explored the UK’s new Post-Market Surveillance regulations reshaping medical device safety, compliance, and improvement.
• A useful guide to required documentation for meeting QMSR and ISO 13485:2016 requirements, compiled by Brian Newberry.
• Matthew Wictome reframed risk management as insight-driven in his recent publication, The Risk Illusion.
• A breakdown on closing CAPAs effectively showcased the need for balance across skills, culture, and leadership, as revealed by Georg Digel.

🗓️ Upcoming Events & Webinars

• Building a MedTech Market Pathway: Aligning Regulatory, Reimbursement, and Commercialization Teams Early | Wednesday, November 12, 2025 • 11:00 AM ET • FREE Online | Subject Matter Experts: Michelle Lott (leanRAQA), Fernanda Nusbaum (TTi Health), Renae Franz (leanRAQA). >> Register now!
• Friday in Focus (MLVx): The Five Biggest Stumbling Blocks Small Device Teams Hit in Study Start-Up (and What to Do Next) | Friday, November 14, 2025 • 11:00 AM ET • FREE Online | Guest Speakers: Laura Van Vaeck and Rob Bedford (Franklyn Health). >> Register now!
• Clinical Data Transferability: Strategies for Leveraging Cross-Regional Evidence | Thursday, November 20, 2025 • 10:00 AM ET / 4:00 PM CET • FREE Online | Speakers: Jessica Addison (Cerapedics Inc.), Leslie Hammermueller (AKRA Team), Richard Holborow (BSI). >> Register now!
• MedTech Malta Summit 2025 | November 12–14, 2025 • Valletta, Malta • Mediterranean Conference Centre - Flagship summit with 2,000+ attendees, StartUp Pitch competition, and Awards gala. >> More information

💥 Weekly 510(k) Roundup — Week of Nov 03 2025

From Marcus Engineering, LLC - Subscribe now!

73 total clearances across 15 categories | 12 first-time recipients 🚀 Including:

• Boston Scientific – Obsidio™ Conformable Embolic (K253376) - Injectable gel used to block blood flow, whether to stop internal bleeding or starve a tumor. It flows like a liquid, then gently firms to the exact shape of the vessel. (30 days, -123 days)
• Ceribell – Instant EEG Headcap (K251381) - Soft, wireless cap delivering rapid EEG readings in emergency settings. Detects seizures in minutes instead of hours, giving ER teams a fast, clear read on brain activity. (182 days, +42 days)
• Inari Medical – Protrieve® Sheath (K253323) - Self-expanding sheath that catches clots before they move into dangerous territory. Opens like a funnel inside the vein to guide clot-removal devices while reducing blood loss. (29 days, -124 days)

📋 From Martin King’s Regulatory Roundup

View the November 3, 2025, Issue

• EU: EC clarifies RMS selection under CTR Art. 85(2)(c) (sponsor-proposed RMS preferred); EMA integrates signal management with PSUSA and updates pre-submission procedures; EDPB issues AI guidance requiring purpose limitation, transparency, and human oversight; MedTech Europe supports eIFUs for near-patient tests and harmonized CGM ISO standard.
• UK / Switzerland / Spain: MHRA & BP release RCV test guidance for AAV/Lenti/Retro vectors (PCR alone insufficient); Swissmedic introduces new ATMP and vigilance forms with eConsent + rSDV permitted (Nov 2024); Vet PV 2024 reports +42% ADRs YoY with 16 safety signals.
• Americas: US FDA drafts QMSR alignment for PMA/HDE submissions and menstrual product guidance on ingredients and biocompatibility (ISO 10993); Brazil ANVISA reclassifies nasal saline as a medical device under RDC 751/2022 (2-year transition).
• Asia / China / Middle East / Africa: NMPA (China) issues 15 new medical device standards covering AI cytopathology, robotic surgery, infusion pumps, dentistry, and tissue engineering.

Cross-Cutting Trends: Ongoing regulator convergence around AI oversight, evidence harmonization, and capacity shortages for legacy device renewals.

📺 In Case You Missed It

Friday in Focus Replay: Inside Brazil’s MedTech Market — What Global Companies Need to Know - The first in our new country-focus series explored how Brazil regulates, tests, and commercializes medical technologies —from ANVISA’s RDC 751 and MDSAP framework to the emerging clinical and investment landscape.

Featuring Bruno Oliveira (MSC MED) and Sean Smith (MedTech Leading Voice), with data from Michelle Wu (Nyquist AI) and participation from Martin King.

👉 Watch the Replay & Download the Slides

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