EU AI Act Quality Management Gets Its First Harmonized Standard

MedTech Leading Voice | Issue 186

📝 From the Editor

Danny Van Roijen reported that EN 18286:2026, a quality management system standard, is the first harmonized standard published under the EU AI Act. COCIR proposed revising the MDR/IVDR toward a single regulatory pathway for AI-enabled medical technologies, and Chi-way Li broke down how FDA-authorized medical AI devices get paid.

On Friday, Juan Daccach MD , showed us where the user belongs in the risk file.

— Sean Smith

🧠 Featured Post

EU AI Act Quality Management Gets Its First Harmonized Standard

EN 18286:2026, “Artificial intelligence - Quality management system for EU AI Act regulatory purposes,” has been published in the EU’s Official Journal. Danny Van Roijen reports that it is the first harmonized standard under the AI Act that can be used to provide presumption of conformity for the related provisions.

Many MedTech manufacturers already rely on harmonized standards for presumption of conformity under the MDR and IVDR. The AI Act now has its first one, and it covers the quality management system. In the same week, COCIR proposed a revision of the MDR/IVDR toward a single regulatory pathway for AI-enabled medical technologies.

View the post >>

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

• What MDR and IVDR Require for Post-Market Surveillance Data Collection, clarified by EU MDR Compliance.
• The Payment Models Behind FDA-Authorized Medical AI Devices, broken down by Chi-way Li.
• 10 Considerations for Translating Device Documentation Into French Under the EU MDR, shared by Emi Lecret.
• Common Planning Gaps in Biocompatibility Evaluations, discussed by Marina Daineko in a recent interview.
• EU AI Act Quality Management Gets Its First Harmonized Standard, announced by Danny Van Roijen.
• Controlled Language Can Improve Medical Device Instructions for Use, Manfred Maiers examines its role.
• 110 Documentation Requirements Inside ISO 13485, identified by Darrin Carlson for QMS development and auditing.
• A Global Regulatory Strategy for Launching Devices in Multiple Markets, presented by Meditrial.
• Developing and Commercializing an FDA-Cleared Smart Ring, with insights from Scott Nelson.
• Regulatory Market-Entry Assessments and Evidence-Based Decisions, emphasized by Mike Wetherington.
• FDA’s Evolving Cybersecurity Expectations for Medical Devices, overviewed by Mitch Robbins.
• One Regulatory Pathway for AI-Enabled Medical Technologies Under a Revised MDR/IVDR, proposed by COCIR.

🎯 Featured Event

Friday, October 23, 2026, 11:00 AM ET — Want More Referrals? A MedTech Business Development & Referral Networking Session

Referrals are one of the most valuable sources of new business for MedTech consultants, vendors and service providers. Building and managing a formal referral program takes time, money and resources that many smaller companies and independent consultants don’t have.

This Friday In-Focus, I’m introducing the MLVx Referral Program, a turnkey referral network that helps MedTech consultants, product and service providers, and technology vendors generate new business through qualified introductions. Regulatory and quality consultants, clinical research organizations, notified bodies, testing laboratories, software providers and other MedTech businesses are invited to an interactive working session.

We’ll discuss:

• What kinds of clients and projects participants are looking for
• How to identify and exchange qualified business referrals
• How referral fees can reward introductions that result in new business
• How members can participate without building and administering their own referral systems

Interested participants can become founding members and help shape how the program operates. Come prepared to share what your company does, what referrals you’re looking for and what opportunities you can offer other members of the MedTech community.

Register Now >>

🗓️ Upcoming Events & Webinars

• 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 >>
• October 23, 2026 | 11:00 AM ET — Want More Referrals? A MedTech Business Development & Referral Networking Session, featuring Sean Smith (Publisher, MedTech Leading Voice). Register Now >>
• October 29, 2026 | 11:00 AM ET — Your Commercial Training Is Part of HF Validation, featuring Liz Cumby (CEO, Cumby Consulting) and Denise Forkey (Director, Human Factors Strategy & Advisory, ClariMed). Register Now >>
• October 30, 2026 | 11:00 AM ET — AI Pre-Submission Review Under the MDR, featuring Marc Gerlach (CEO, phablo.ai). 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

October 12, 2026 | From Marcus Engineering, LLC

42 clearances this week, including 20 first-time clearances (🚀).

Featured clearances:

• 🚀 Fertilis — microICSI Device: a tiny 3D-printed tool that makes IVF procedures gentler on human eggs. Embryologists usually hold the egg still with suction, which can stretch and deform the cell. Fertilis uses a tiny holder instead, which reduces physical stress and makes the procedure easier to perform.
• 🚀 IVT Medical Ltd. — MeCare Alpha: a portable, rechargeable system that delivers vacuum wound therapy for hard-to-heal wounds such as diabetic ulcers or surgical incisions. Patients can carry it with them and keep healing at home.
• E2 - Endovascular Engineering — Hēlo Return: collects the blood that comes out during suction removal of lung clots, separates it from the removed material, and returns it to the patient so less blood is lost.

Explore the update >>

📋 Regulatory Roundup

12 October 2026 | By Martin King

This edition covers:

• Health Canada requires updated bioequivalence and BCS-based biowaiver templates from 6 October 2026.
• MHRA and EMA updated guidance on Type II variations, post-authorisation procedures, submission timelines and documentation.
• ANVISA’s implementation plan for ICH E8(R1) and E6(R3) brings Brazil closer to modern Good Clinical Practice and risk-proportionate trial oversight.
• Health Canada revised its guidance on medical-device shortage reporting, exceptional importation and foreign-authorisation notifications, with amendments taking effect in June 2027.
• Swissmedic updated materiovigilance forms and hospital inspection materials covering incident reporting, traceability and vigilance responsibilities.
• The UK accepted all 44 recommendations of the National Commission on healthcare AI.
• IMDRF and ICH work covers AI/ML, SaMD, cybersecurity, UDI and harmonised clinical-research standards.
• FDA and MedTech Europe expanded access to the Total Product Life Cycle Advisory Program (TAP) and discussed robotic-assisted surgery.

Explore the update >>

🎤 In Case You Missed It

A Broken Instrument Falls Into the Patient. What Happens Next?

On Friday, 123 attendees from 29 countries heard Juan Daccach, MD, put the user inside the risk file. Juan is an orthopedic surgeon and was global medical safety officer for joint reconstruction at Johnson & Johnson.

During the session, he described the use-related risk assessment (URRA) as a bridge across the whole product lifecycle: pre-launch creates it and post-launch updates it. Nine of 12 poll respondents spotted the column missing from FDA’s URRA table, which is probability of occurrence. FDA defines a critical task by how badly someone could be hurt, and Juan warned against “mitigation by math.”

He then cited 1,557 robotic surgery reports of a broken or burnt instrument piece falling into the patient. Nine of 18 respondents expected conversion to open surgery. The data says the team stops to search for the piece and retrieve it. As Juan put it: “A machine failure or a device failure creates a human task.” That task needs its own row.

Juan is open to his next medical safety role. Connect with him on LinkedIn >>

Watch the replay >>

🔥 Postscript

Meet me in Prague

I’m in Europe this week, traveling with my brother through Northern Italy and Switzerland. Turin is next, where I’ll visit the Shroud. Then I fly to Prague for the TEAM-PRRC Annual Summit on October 29 and 30. If you’ll be there, come find me.

Sean 🐝