Notified Bodies Get Maximum Timelines Under Regulation (EU) 2026/977

MedTech Leading Voice - Issue 184

📝 From the Editor

Regulation (EU) 2026/977 puts maximum timelines on notified body conformity assessments under the MDR and IVDR, and caps how often a notified body can stop the clock. EU MDR Compliance laid out the numbers this week, and Tibor Zechmeister's 12 skills for RA work under the EU MDR make a good companion read.

— Sean Smith

🧠 Featured Post

New conformity assessment timelines for notified bodies under Regulation (EU) 2026/977

EU MDR Compliance detailed the maximum timelines the Commission set in May for notified body work under the MDR and IVDR. Application review and contract signature get 30 days. QMS auditing gets 120 days to the final review, and technical documentation assessment gets 90. Interruptions are capped per phase, including four for QMS auditing and four for the technical documentation assessment.

For manufacturers, the regulation makes certification planning more predictable and adds a way to compare notified bodies. Each notified body must monitor the duration and cost of its conformity assessments and publish an annual report by 30 April, with reporting obligations starting 1 January 2028. When a timeline expires, the notified body continues the assessment until it reaches a decision.

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

• ↳ Notified Bodies Have New Conformity Assessment Timelines Under Regulation (EU) 2026/977, EU MDR Compliance sets out the limits.
• The 12 Essential Human Factors References for Medical Device Development, compiled by Annmarie Nicolson.
• Your CAPA Was Implemented. Was It Effective?, Georg Digel on the difference between the two verifications.
• The Medical Device Value Proposition Now Spans Clinical, Workflow, Economic and Outcome Value, Ryan M. Graver explores how it is evolving.
• What Human Factors Testing Teaches About Use-Related Risk, key lessons from Nilabha Mukherjea.
• Should You Pen Test SaMD the Same Way as a Hardware-Embedded Device?, Sean Satterlee compares the approaches.
• Commercialization Gets Complicated After FDA Clearance, Thomas Ross illustrates what comes next.
• How to Manage Supplier Documentation During an MDSAP Audit, practical strategies from Danny Kroo.
• The European Parliament Studied an AI-Supported Platform for Preventive Healthcare, Danny Van Roijen covers the study.
• 20 Ways AI Can Work Within the European Health Data Space, identified by Sigrid Berge van Rooijen.
• This Week in AI, Biocompatibility and Global Device Regulation, from Marina Daineko's weekly Monday News.
• Build or Buy AI Software? The Choice Has Long-Term Consequences, Richard Kedziora on what to weigh.
• A Real FDA Inspection Remediation Case, and How to Prepare for One, Foteini Stroumpouli walks through it.
• Absorbable and Degradable Devices Raise Their Own Biocompatibility Questions, Intrinsic Medical Group discusses them.
• 12 Practical Skills for Regulatory Affairs Work Under the EU MDR, broken down by Tibor Zechmeister.
• FDA Released the 510(k) Summaries for AI Devices Authorized in September 2026, with a preliminary read from Yujan Shrestha, MD.

🎯 Featured Event

Friday, October 9, 2026, 11:00 AM ET —Active Medical Devices R&D: Uruguay Is Closer Than You May Think

Next week on Friday In-Focus, Mauricio Gonzalez Genta, CTO of Focus, makes the case for why a U.S. or European company might want to work with an R&D team in Uruguay. I've met the team, and they are very good. We'll be talking about implantable and wearable devices.

Register Now >>

🗓️ Upcoming Events & Webinars

October 14, 2026 | 12:00 PM ET — Demystifying the FDA: Five Steps to the U.S. Market, featuring Michelle Lott, RAC (Principal and Founder, leanRAQA). Register Now >>

October 22, 2026 | 11:00 AM ET — Clinical Project Management: The Hidden Complexity of Medical Device and IVD Studies, featuring Daniela Karrer (VP Operations and Clinical Affairs, Donawa Lifescience), Matteo Mosso (Director, Clinical Affairs, Donawa Lifescience) and Elena Arcangeli (Clinical Project Manager, Medical Device Companies). Register Now >>

🎟️ Upcoming Conferences

• October 26–27 | Munich, Germany — The European Conference on Digital Transformation & Data in Medical Technologies (DTD2026), chaired by Clara Pessy of Platomics. Two days of keynotes, panels and industry symposia on AI-enabled medical devices, SaMD, regulatory innovation and clinical evidence generation, with Martin King among the speakers. MLV readers get 20% off registration with the code MEDTECH20. Register Now >>
• October 29–30 | Prague, Czech Republic — TEAM-PRRC Annual Summit 2026, fifth edition, at the Hilton Old Town. The European meeting for Persons Responsible for Regulatory Compliance and regulatory affairs professionals in medical devices. Register Now >>
• November 3–5 | San Diego, CA — MedTech Strategist Innovation Summit San Diego 2026 at The US Grant Hotel. A medical device partnering and investment conference. Attendee registration covers all sessions, meals, networking, and the JuJama partnering app. Register Now >>
• November 10–11 | Philadelphia, PA — PhMTI 2026 Fall Seminar: Human + Machine, The Enduring Value of Information Professionals in the Age of AI, at the Sofitel Philadelphia at Rittenhouse Square. Member rate $200. Register Now >>

💥 Weekly 510(k) Roundup

September 28, 2026 | From Marcus Engineering, LLC

64 clearances this week, including 25 first-time clearances (🚀).

Featured clearances:

• CapsoVision, Inc. — CapsoView / CapsoCloud: a swallowable camera capsule takes a 360° view as it moves through the small intestine, helping doctors look for bleeding and other problems in a part of the digestive tract that is hard to reach with a traditional scope. The images are stored inside the capsule, so patients do not have to wear an external recorder.
• Aevice Health — Wheeze Detection Module: works with a small wearable stethoscope worn on the chest to detect wheezing automatically, including at home while a child is sleeping. Catching changes earlier gives parents and doctors more time to respond.
• SimBioSys — TumorSight Risk: uses AI to estimate whether a patient's breast cancer is likely to return within five years, combining breast MRI images, pathology results, and basic patient and tumor information into a risk score. That can help doctors decide how aggressive treatment should be.

Explore the update >>

📋 Regulatory Roundup

28 September 2026 | By Martin King

Martin King reads this week as regulators moving from policy to implementation across medicines, medical devices and IVDs:

• NMPA's revised medical device GMP inspection framework takes effect 1 November.
• Swissmedic's revised Article 41 MPLO requirements are now valid, including major AI/ML system changes.
• FDA launched a NAMs use-case database and issued draft guidance on robotically-assisted surgical devices.
• MHRA updated its national assessment, pre-submission and variations guidance.
• ENISA published AI-assisted software-development guidance and its Threat Landscape 2026.
• The edition also covers the European Commission and EMA, Egypt's EDA, SAHPRA and WHO.

Explore the update >>

🎤 In Case You Missed It

Compliant, and Still Wrong: The Human Side of Risk Decisions

You can follow every clause of ISO 14971 and still ship a device that fails in the field. Last Friday, Steve Gompertz of QRx Partners and Jean Blom of MedAce explained why. The standard describes risk management like clockwork, and real risk work runs on judgment: someone who knows what each analysis is for and will defend the decision when an auditor or a field failure asks.

As Blom concluded: "If you were bereft of all of your tools and you could not change anything you did in the past, would you still feel comfortable standing there, explaining what you did?"

[Watch the replay >>](LINK NEEDED)

🔥 Postscript

Meet me in Prague. I'm in Europe from mid to late October, finishing at the TEAM-PRRC Annual Summit on October 29–30. If you'll be there, send me a message and let's find time.

See the program >>

Sean 🐝