EU Proposes Free Access and Fixed Deadlines for Harmonized Standards

MedTech Leading Voice - Issue 185

📝 From the Editor

On October 6, the European Commission proposed a new Standardisation Regulation. It would make the harmonised standards the Commission requests free online and set deadlines on how they get made. CEN and CENELEC support the goal and warn that parts of the proposal could fragment the system. EU Business and Martin King also covered the reform this week, and David Filmore reported the first devices selected for EU Joint Clinical Assessment.

— Sean Smith

🧠 Featured Post

CEN and CENELEC respond to the Commission’s proposed Standardization Regulation

The proposal would replace Regulation (EU) No 1025/2012. Standards the Commission requests and references in the Official Journal would become free online. The Commission would get deadlines of its own, including six months to assess a delivered standard and three months to publish its reference. Where no harmonized standard exists, it could adopt common specifications by implementing act. The target is to cut the average time from identified need to Official Journal reference from 6.1 years to 4.0.

Many manufacturers rely on harmonized standards for presumption of conformity under the MDR and IVDR. For them, the proposal means free access and, if the targets hold, faster references. CEN and CENELEC support faster, more effective standardization, but say in their press release that “several elements of the proposal risk weakening the very system it seeks to improve.” The proposal now goes to the Parliament and the Council, and the Commission expects it to enter into force in 2028.

View the post >>

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

• CEN and CENELEC Respond to the Commission’s Proposed Standardization Regulation, CEN and CENELEC set out their position.
• What IEC 62366-1 Requires for Usability Validation, clarified by Tibor Zechmeister.
• Claims-to-Evidence Traceability Can Sharpen Regulatory and Portfolio Decisions, Dr. Shola Sulaimon outlines how.
• The EU Proposes a New Regulation to Modernize European Standardization, from EU Business.
• The European Parliament Studied Health Data and AI in Medicine, highlighted by Danny Van Roijen.
• Human Error Belongs in Your CAPA Root-Cause Investigation, Danny Kroo on why it matters.
• AI Risk Management Runs Across the Whole Device Lifecycle, Manfred Maiers explores it.
• Wearables Are Taking On a Larger Clinical Role, Renuka Dixit discusses the trend.
• 510(k), De Novo or PMA?Meditrial breaks down the differences.
• FDA Takes a Risk-Based Approach to Human Factors Evidence in Submissions, detailed by Dr. Fatima Sanfourche.
• Penetration Testing AI-Enabled Medical Devices Against Emerging Threats, Sean Satterlee examines the strategies.
• The First Medical Devices Selected for EU Joint Clinical Assessment, announced by David Filmore.
• 14 Influential Research Papers on AI in Healthcare, compiled by Sigrid Berge van Rooijen.
• Canada Updated Its Medical Devices Regulations, with an overview from Documedex.
• EU Standardization Reform Can Advance Innovation and Market Access, Martin King on the role it plays.

🎯 Featured Event

Friday, October 16, 2026, 12:00 PM ET — The User in the Risk File: Bridging Medical Safety, Usability and Risk Management

Next week on Friday In-Focus, Juan Daccach, MD, a medical device subject matter expert, puts the user inside the risk file, using surgical robotics as the example. He isn’t selling anything. He’s coming on to educate.

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

October 5, 2026 | From Marcus Engineering, LLC

59 clearances this week, including 26 first-time clearances (🚀).

Featured clearances:

• 🚀 Brainlab SE — Spine Planning and Spine & Trauma Navigation: surgeons build a 3D plan before surgery, then use it in the operating room to guide screws and implants in real time. Spine surgery happens around nerves and other critical structures, where even small placement errors can have serious consequences.
• Spinal Alignment Solutions (SAS) — SAS MIS Pelvic Incidence Rods: pre-shaped spinal rods designed around a patient’s pelvic anatomy and natural spinal curve, so the surgeon starts with a shape closer to where that patient’s spine should end up instead of bending a generic rod in the operating room.
• Centerline Biomedical— IOPS / IOPS Visionary System: a 3D map of the patient’s blood vessels that shows where catheters and guidewires are moving in real time, which can reduce dependence on X-rays and contrast dye.

Explore the update >>

📋 Regulatory Roundup

5 October 2026 | By Martin King

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

• Singapore’s HSA applies Concurrent Change Notification processing and a Premarket Submission Checklist from 1 October, with full enforcement of submission completeness from 1 January 2027.
• Malaysia’s Medical Device Authority updated its product classification rules, with revised validity, renewal and processing requirements from 1 October.
• Swissmedic updated requirements for combined studies, establishment licences and swissdamed UDI.
• CECP activity from the European Commission and EMA reinforces the link between intended use, clinical evidence, benefit-risk, comparative evidence and follow-up.
• HPRA and MHRA updated guidance on manufacturer-authorisation and marketing-authorisation variations.
• IMDRF and HSA work covers AI/ML, PCCPs, cybersecurity and software lifecycle management.
• The edition also covers FDA and TGA updates on E2B(R3) electronic safety reporting and new Australian medicine-labelling standards.

Explore the update >>

Explore the update >>

🎤 In Case You Missed It

Uruguay Is Closer Than You May Think

On Friday, more than 69 attendees heard Mauricio Gonzalez, CTO and co-founder of Focus in Montevideo, trace Uruguay’s device industry back to a pacemaker implanted there with leads made on a guitar-string machine. When asked about past work with teams abroad, attendees cited time zones and cultural fit as their biggest problems. Gonzalez answered with a neuromodulation client. Focus asked whether the device needed to plug into the wall, and the switch to USB-C charging cut the design from three boards to one.

As Gonzalez said: “This doesn’t happen if you just have a team that is saying yes sir to whatever thing you ask them to do.”

Watch the replay >>

🔥 Postscript

When is a toothpick a medical device?

The wooden ones aren’t. The ones with floss are Class I in the U.S. On Friday I floated a group exercise: a make-believe connected T-Pick Pro that checks for gingivitis and talks to your dentist. We’d do the full regulatory, quality, design, and commercialization workup together the day after Thanksgiving.

Seven people said yes in the chat. One person called it idiotic, with a smiley.

Want in? Send me a message.

Sean 🐝