Our November 2025 MedTech news brings you the latest on the EU Commission’s Digital Omnibus proposal, calls for EU reference lab applications for high-risk IVDs, and Team NB’s guidance on MDR and IVDR. Updated FDA and Health Canada regulatory documentation spanning Pre-RFD preparation, comparative efficacy studies, QMSR requirements, and MDL applications also feature, as well as China’s comprehensive medical device GMP overhaul. Read on for more…

EU Commission publishes Digital Omnibus Regulation proposal

Published this month, the Digital Omnibus proposal includes a set of technical amendments to a large quantity of digital legislation, selected to bring immediate relief to businesses, public administrations, and citizens, and to stimulate competitiveness. Aiming to ensure cost-effective compliance and offering a competitive advantage to responsible businesses, the proposal is a first step in optimising the application of the digital rulebook.

MedTech Europe has welcome the omnibus – but has urged policymakers to go further in simplifying and harmonising digital regulations, saying that fragmented and overlapping rules currently hinder innovation and patient access in the MedTech sector.

Find out more about the Digital Omnibus proposal here, and read its assessment from MedTech Europe here.

EU Commission calls for EURL applications for certain class D devices

The EU Commission designates EU reference laboratories (EURLs) to support conformity assessment of high‑risk class D in vitro diagnostic devices. Current labs cover viruses, bacteria, and blood grouping, while new calls in 2025–2026 aim to expand coverage to parasites and other pathogens where no labs yet meet criteria.

Applications are now open for EURLs handling any of the following device categories: detection or quantification of markers of hepatitis, retrovirus, or herpesvirus infection, infection with bacterial agents, arbovirus or respiratory virus infection, infection with haemorrhagic fever viruses or other biosafety level 4 viruses, parasite infection, or detection of blood grouping markers.

Laboratories are asked to submit their applications to their Member States by the 15 January next year (timing indicative dependent on Member State). Find out more here.

MedTech Europe: Time to digitalise near-patient testing

MedTech Europe recently published “Greener, Smarter Healthcare: Electronic Instructions for Near-Patient Tests” – highlighting how digital transformation can make clinical practice more efficient and sustainable.

The booklet emphasises how switching from paper to electronic Instructions for Use (eIFUs) in near‑patient testing would improve efficiency, accuracy, and sustainability, aligning clinical practice with modern digital healthcare needs. Read more about the booklet here.

Team NB shares position paper on MDR application & appropriate surveillance transfer agreement

This month, Team NB released a position paper that provides a template agreement for transferring MDR formal applications and appropriate surveillance of legacy devices between Notified Bodies, ensuring clear terms when certificates under the old Directives are moved to MDR oversight. Read the position paper here.

Team NB clarifies interpretation of significant changes under IVDR

At the end of last month, Team NB published a position paper that clarifies how Notified Bodies interpret significant changes to companion diagnostic devices under the IVDR. It explains that any modification affecting performance, suitability, or intended use, requires consultation with medicinal product authorities, ensuring consistent regulatory oversight across the EU. Find out more here.

China’s NMPA overhauls its GMP for medical devices

China’s NMPA has issued a major overhaul of its Good Manufacturing Practice (GMP) for medical devices, expanding from 15 provisions in 2014 to 132 provisions in 2025. The revision aligns with ISO 13485, EU MDR, and FDA QMSR, and introduces risk‑based requirements across the entire product lifecycle to strengthen quality, accountability, and continuous improvement.

The 2025 GMP for medical devices strengthens lifecycle risk management, introduces structured quality assurance, clarifies contract manufacturing responsibilities, elevates verification and validation requirements, and promotes digitalised, intelligent production to align with global standards and support smoother market entry for overseas manufacturers.

Find out more about the revision here, and what it means for overseas manufacturers here.

FDA releases final guidance on Pre-RFD preparation

This month, the FDA released final guidance that explains how to use the Pre-Request for Designation (Pre-RFD) process to obtain informal, non-binding feedback on whether a medical product should be classified as a drug, device, biologic, or combination product, and which FDA centre will oversee its review. Access the final guidance here.

FDA shares updated recommendations for assessing comparative efficacy study need

The FDA has shared draft guidance outlining updated recommendations on when comparative efficacy studies are needed to demonstrate that a proposed therapeutic protein product is biosimilar to a reference product, for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act). You can read the draft guidance, and submit comments by the 20 January, here.

FDA issues draft guidance on QMSR requirements

The FDA has issued draft guidance to outline expectations for quality management system regulation (QMSR) requirements for premarket submissions once the final rule amending 21 CFR part 820 takes effect.The document explains that medical device manufacturers must align their Quality Management Systems with ISO 13485:2016 when preparing premarket submissions, ensuring compliance with updated QMSR requirements. You can read the draft guidance, and submit comments by 16 January, here.

Health Canada proposes second phase of regulatory amendments to its MDR

Health Canada’s phase two proposal seeks to modernise the Medical Device Establishment Licensing framework – to streamline requirements by exempting foreign distributors using Canadian importers, mandating documented procedures, and requiring disclosure of suppliers. Read more on the proposal here.

Health Canada shares new guidance on MDL applications

Effective February 2026, Health Canada’s new guidance explains how it will manage medical device licence applications (MDLs) for class II, III, and IV devices, as well as minor change applications and new and amendment private label applications. The document aims for consistency and predictability with clear timelines and performance standards. Read the guidance here.

That concludes our November 2025 MedTech news roundup – our last bulletin for this year. We’ll be back in 2026 with more medical device news and updates.

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