UK Device Rules Get a Long-Awaited Rewrite

MedTech Leading Voice | Issue 164

📝 From the Editor

Huge thanks to everyone who sent birthday messages last week. 60 feels like a good place to keep building from. Thank you for being part of the journey.

A reminder:MLV100 2026 voting closes May 30. Cast your vote and nominate anyone we missed at mlvx.ai/mlv100.

Also, big thanks to Alper Hulusi for last Thursday's webinar on Real-World Use Research. Recap below >>

— Sean Smith

🧠 Featured Post

The Draft UK Medical Devices (Amendment) Regulations 2026

Ian Sealey flagged the publication of the long-awaited draft UK Medical Devices (Amendment) Regulations 2026.

Key proposed changes include:

• International reliance scheme providing faster routes to market for certain devices and IVDs
• Classification changes for more risk-proportionate regulation
• Enhanced safety and performance requirements with closer alignment to international approaches
• More comprehensive technical documentation, including longer retention periods
• Strengthened equivalence requirements
• Mandatory UDI for devices and IVDs, plus implant cards for implantables
• Regulation of misleading or unsubstantiated device claims
• Broader allowances for electronic instructions for use

For teams selling into the UK, this is the structural shift to plan around. View the post >>

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

• Danny Van Roijen announced EU draft guidelines on AI Act Article 50, ahead of the August 2026 deadline.
• Weak design validation and the FDA’s continued push for real-world user evidence in medical device development were discussed by John Salvato.
• Sigrid Berge van Rooijen underscored risks tied to the EU AI Act delay, including unclear standards and lack of system readiness.
• Updated national requirements for clinical investigations and performance studies across EU Member States shared by EU Health and Food Safety.
• The implications of contradictory product labeling and the importance of addressing foreseeable misuse in QA/RA risk decisions were noted by Karan Dhamija.
• F. David Rothkopf overviewed the FDA’s pilot of unannounced one-day inspections for low-risk device companies, emphasizing the need for continuous inspection readiness.
• Upcoming changes to IEC 60601-1 Edition 4 on evolving mechanical hazard frameworks and impacts on design and testing, were detailed by Leonard (Leo) Eisner.
• Clause 17’s role in linking EMC testing to risk management and shifting accountability to manufacturers, highlighted by Beat Keller.
• Dr. Paresh Dadhaniya emphasized ISO 10993 as a framework for biological evaluation versus a checklist approach.
• Updated EU survey results on medical device availability and notified body certifications were underlined by Mario Gabrielli Cossellu.

🎯 In Case You Missed It

Real-World Use Research with Alper Hulusi

More than 500 registered for last Thursday's webinar with Alper Hulusi and Jessica Parry for a 60-minute walk-through of three Real-World Use Research programs: implantable neurostim for chronic conditions, CGM and insulin for Type 1 diabetes, and a rehab device for post-stroke aphasia.

In short, the barriers look very different across devices, users, and buyers.

For neuromodulation, three audiences must each say yes: the implanter, the referring clinician, and the patient living with it. For diabetes, stress, food, sleep, and a tight reimbursement window shape adoption. For stroke rehab, caregivers and outcomes contracts drive the daily reality.

Watch the replay and download the slides >>

🗓️ Upcoming Events & Webinars

• May 22, 2026 | 11:00 AM ET — The 7 Deadly Sins of Test Method Validation, featuring Simon Föger, CEO & Founder of SIFo Medical.
• May 28, 2026 | 12:00 Noon ET — From Observation to Action: What FDA Expects After a 483, featuring Michelle Lott and Tianna Benson from leanRAQA.

🔥 NEW Virtual/In-Person Event - June 1, 2026 | Boxborough, MA — IEC 60601-1 4th Edition Seminar,an Overview and Q&A with Members of the Standards Team. Free in-person seminar hosted by Leo Eisner and TÜV Rheinland.

Register to join >>

• June 2–5, 2026 | Boston — IMSC26 International MedTech Safety Conference. Use MLV codes to register: MLV$200 (general), Start$250 (startup in-person), StartEd$50 (startup education day).
• June 12, 2026 | 11:00 AM ET — In Silico Evidence and the Future of Clinical Evaluation, featuring Surash Surash, Clinical Reviewer at TÜV SÜD.

💥 Weekly 510(k) Roundup

May 11, 2026 | From Marcus Engineering, LLC

38 total clearances this week across multiple categories, including 10 first-time clearances (🚀).

Featured clearances:

• IntroMedic Co., Ltd.— MiroCam® Capsule Endoscope System: a pill-sized capsule with camera, light, battery, and wireless transmitter that captures and sends images as it moves through the digestive system.
• Sebia— Alegria Flash SSA-60, SSA-52, SSB: autoimmune assays supporting identification of markers tied to conditions like Sjögren's syndrome and lupus.
• Heidelberg Engineering— SPECTRALIS HRA+OCT with Flex Module: movable imaging head offering flexibility for retinal imaging in patients with mobility challenges.

Full breakdown available in the May 11, 510(k) Roundup >>

📋 Regulatory Roundup

May 11, 2026 | By Martin King

This week's global regulatory landscape shows clear movement toward harmonisation, digitalisation, AI integration, and lifecycle-based oversight across MedTech, IVDs, pharmaceuticals, and clinical research.

Major updates came from the European Commission, EMA, EDQM, FDA, ANVISA, Egyptian Drug Authority, Swissmedic, TGA, HPRA, SAHPRA, MHRA, WHO, ISO, and MedTech Europe.

Key threads: EU MDR/IVDR reform and structured recertification, expansion of AI governance frameworks, rising focus on cybersecurity and UDI implementation, strengthened data integrity expectations, and continued growth in post-market surveillance and real-world evidence. Explore the update >>

🔥 Postscript

MLV100 2026 — Voting Closes May 30

Cast your vote for the 100 MedTech Leading Voices worth following in 2026, and nominate anyone we missed. Vote now >>

Sean 🐝