Regulatory Intelligence | May 2026
Classification changes, EUDAMED deadlines, and global compliance shifts shaping MedTech market access.
Prepared by SciMed Consultancy Ltd for regulatory, legal, quality, and market-access teams operating under EU MDR, IVDR, UK MDR, and related global frameworks.
THIS MONTH IN BRIEF
• EU classification guidance revised for the first time since 2021
• EUDAMED mandatory module activation begins 28 May
• IVDR Class C application deadline now weeks away
• UK annual MHRA registration fee model now active
• Health Canada tightens significant-change interpretation
• FDA confirms AI/ML lifecycle guidance remains FY2026 priority
INTRODUCTION
April was the busiest month for EU classification guidance since the original MDR rollout, with the MDCG releasing the first revision to its 2021-24 classification document, a new version of the borderline manual, and updated FAQs covering supply continuity and EMDN coding. Three weeks out from the 28 May EUDAMED switchover and the parallel IVDR Class C application deadline, we've been tracking how this guidance bundle is being interpreted across our client base, where the genuine implications sit, and what manufacturers should action before the rush.
RECENT DEVELOPMENTS - EU
MDCG 2021-24 Rev.1: Classification Guidance Refreshed for the First Time in Four Years
Published on 20 April 2026, Revision 1 of MDCG 2021-24 is the first substantive update to the EU's flagship classification guidance since the document's original release in October 2021. The revision doesn't rewrite the rules but it does sharpen the interpretation. Key terminological shifts include replacing "surgical" with "clinical" when discussing invasiveness for implantables, and standardising on "product" rather than "device" across the application of the rules. Notes and examples have been added or revised under Rules 2, 8, 9, 10, 12, 16 and 22. The most concrete practical change concerns AED accessories: pads and electrodes placed on the market on their own, rather than as integral parts of an AED system, are no longer automatically Class III under Rule 22 and should be classified under Rule 9 or Rule 1 based on their own characteristics. Manufacturers with active devices, sterilisers, accessory products or implantables in the portfolio should pull the previous classification rationale and check that the underlying logic still holds.
»You can read the guidance document here.
Manual on Borderline and Classification: Version 5
The Borderline and Classification Working Group released Version 5 of the manual on 22 April 2026. The notable additions are a new section on medical devices used to administer medicinal products, with worked examples of how specific products have been evaluated, and new content on saline solutions for nasal irrigation. The glossary has been refreshed to support the new categories. The manual continues to capture rulings agreed via the Helsinki Procedure, so anyone working on borderline cases involving drug-device combinations or nasal/respiratory products should treat V5 as the working reference. Existing classification arguments shouldn't be assumed to carry through automatically.
»You can read the Borderline Manual here.
Article 10a: New Decision Tree and Revised Q&A on Supply Interruptions
The Commission has published Revision 2 of the Q&A on Article 10a alongside a new decision tree to help manufacturers and authorised representatives determine when a supply situation triggers the notification obligation. The decision tree formalises the assessment criteria and expands the discussion of when an interruption becomes reportable, with the practical guidance that a supply interruption exceeding 60 days should generally be treated as in scope. Manufacturers without an established Article 10a procedure should use the decision tree as the basis for an internal SOP, supply continuity is one of the few MDR obligations where notification timing materially affects market positioning and authority relationships.
»You can read the Q&A here.
MDCG 2021-12 Rev.2: EMDN FAQ Revision 2
The MDCG's revised EMDN FAQ is brief but operationally important. It now explicitly requires manufacturers to select the most specific (terminal) EMDN code available and clarifies the process for requesting new codes via the official EMDN update mechanism. With EUDAMED registration becoming mandatory on 28 May, this matters in two ways: device records uploaded with parent rather than terminal codes are likely to attract attention from competent authorities, and inconsistencies between the EMDN code and GMDN code already submitted to other regulators can complicate global registration data.
»You can read the FAQ here.
RECENT DEVELOPMENTS - UK
MHRA Registration and Clinical Investigations Guidance Refreshed: New Annual Fee Structure Live
The MHRA updated its medical device registration guidance on 10 April 2026 (DORS attribute changes and administrative fee detail) and its Clinical investigations for medical devices guidance on 9 April 2026. These accompany the new annual fee structure that took effect on 1 April 2026: registrations now attract a £300 annual fee per Level 2 GMDN category (or Level 1 where no Level 2 exists), invoiced after 1 April and payable within 90 days, replacing the previous one-off charge. Manufacturers should make sure their DORS data is clean before the next billing cycle, obsolete or duplicated GMDN entries will translate directly into fee exposure. The MHRA has signalled it will run a data-cleansing window for manufacturers to remove withdrawn products without charge.
»You can read the guidance here.
MHRA International Reliance and CE-mark Recognition Consultation Closed
The MHRA's consultation on indefinite recognition of CE-marked devices in Great Britain and an international reliance route (covering devices certified in the US, Canada, Australia and the EU) closed on 10 April 2026. We're now in the response window. For manufacturers planning UK market entry on the back of an existing CE certificate, the eventual outcome will determine whether GB access continues to follow EU certification or shifts towards a more independent UKCA pathway. Worth tracking closely over the next quarter.
»You can check the consultation site here for future updates.
RECENT DEVELOPMENTS - USA
FDA Patient Preference Information Final Guidance and New Class II Classification
The FDA published its final guidance on incorporating Voluntary Patient Preference Information across the total product life cycle in April 2026, signalling a more structured role for PPI in pre-market submissions, post-market evidence generation and label development.
Separately, the Federal Register notice classifying the radiation therapy marking device into Class II with special controls became effective on 30 April 2026. Looking forward, CDRH's FY2026 guidance agenda confirms the AI/ML lifecycle management and real-world evidence guidance are the priorities for finalisation; manufacturers building PCCPs into AI submissions should expect the final lifecycle management document during the current fiscal year.
You can see the radiation-emitting guidance documents here, and final amendment on the radiation therapy classificatIon here.
RECENT DEVELOPMENTS - Canada
Health Canada REP Becomes Mandatory and New Guidance on Significant Changes, Terms & Conditions, and Clinical Evidence
As of April 2026, the Regulatory Enrolment Process (REP) is the mandatory submission pathway for medical device licence applications and related transactions, transmitted via the Common Electronic Submissions Gateway. In parallel, Health Canada published new and revised guidance documents covering: the Minister's expanded authority to impose terms and conditions on licences at any point in the lifecycle (effective 1 January 2026); a stricter and more structured interpretation of significant changes, particularly for software, cybersecurity updates and compatibility claims, and clarified clinical evidence expectations for Class II to IV devices. Companies maintaining Canadian licences should review change control procedures against the new significant change guidance as the bar for what triggers an amendment has moved.
You can see the new Health Canda guidance documents here.
UPCOMING DEADLINES
The following confirmed deadlines fall within the next 90 days. Manufacturers, importers, and authorised representatives should verify their compliance status against each.
26 May 2026 - IVDR
Class C self-declared legacy IVD manufacturers must lodge a formal application with a notified body to retain access to the extended transition period to 31 December 2028. Missing this date removes the benefit of the transitional provisions.
27 May 2026 - MHRA
Final date for registration of certain medical devices and IVDs placed on the Northern Ireland market.
28 May 2026 - EUDAMED
First four EUDAMED modules:
Actor
UDI/Device
Notified Bodies/Certificates, &
Market Surveillance
become mandatory. New MDR/IVDR devices placed on the EU market from this date must be registered in the UDI/Device module before first placement.
1 July 2026 - TGA
UDI labelling and AusUDID data submission requirements become mandatory for Class III and Class IIb medical devices.
1 July 2026 - Swissmedic
Mandatory registration of medical devices, IVDs and procedure packs in swissdamed begins (with a transition period running to 31 December 2026).
Need help interpreting how these changes affect your organisation?
Regulatory changes rarely affect products in isolation. Classification strategy, evidence planning, market access, software change control, supply continuity, and lifecycle obligations increasingly overlap across jurisdictions.
If your team is assessing the operational or commercial implications of any of the developments above, we can help pressure-test the impact against your specific products, portfolio, or regulatory strategy.
