18 New EU MDR/IVDR Harmonized Standards & UK Designated Standards
30 January 2026Below is an overview of the January 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., the Commission’s MDR/IVDR reform proposal published to WTO, and 18 new Harmonized Standards.
Europe
New EMDN Codes & EUDAMED Updates
Updated EMDN Codes
In January 2026, the EUDAMED log-in dashboard noted:
“The new version (v3) of EMDN Codes for 2026 will be available in EUDAMED with the deployment of Production v2.22.0.”
Further, the Commission now sends an email notification to users, if their EMDN code has been discarded, split, or scope-reduced. This is a welcome change from the the Commission’s 2025 statement that there was no mechanism to notify impacted companies if their EMDN code had been revised.
Presumably MDCG 2021-12 rev.1 will require an update, as FAQs 12 & 13 still note that “notifications to users is not currently possible” and that EMDN code revisions will be published via MDCG endorsed documents.
Please see more information on this topic below.
EUDAMED Updates
The release notes for Product v2.22.0 are available: HERE
One of the major system updates is related to EMDN Codes. EUDAMED now:
- Shows version history of revised EMDN codes
- Shows a warning to users that the EMDN code has been revised, and action may be required to update their registration entry
- Sends manufacturers an email if their EMDN code has been discarded, split, or scope-reduced
- The system does not send an email if the EMDN code was scope-extended or corrected, as no action is necessary from the manufacturer
- Manufacturers presumably have to manually check if a new EMDN code has been published, that better fits their device (e.g., if they are currently under and “other” EMDN code)
New User Manuals were published, providing further instructions. As well, the applicable information has been added to the EUDAMED Resource Center: HERE
Click on #3 “Enter the EMDN code…” to see the full details and images.
Other changes, such as expanding the Master UDI-DI list of devices to include spectacle frames, lenses, and readers.
MDCG Working Group 2026 List of Planned Meetings
The MDCG published its proposed list of 2026 working group meetings: HERE
They have not yet published an updated list of ‘ongoing/planned guidance development and deliverables’, which was last published January 2025.
MDCG Dec 2025 Working Group Meeting Minutes
The MDCG main working group published its 1 December 2025 meeting minutes: HERE
A few notable topics include:
- The Commission presented the draft delegated acts for expansion of the WET list. Some Competent Authorities raised concerns, such as regarding implant card exemptions. Therefore, the Commission proposed to further discuss certain technical considerations before finalizing the delegated acts, in particular on implant cards. Adoption of the acts is expected in Q1 2026.
- The audit for the vigilance EUDAMED module is planned for Q1 2026, with mandatory use expected by Q2 2027.
- The EUDAMED clinical investigation and performance study modules remain under development.
- The Commission will launch a pilot program for Breakthrough devices (BtX).
- The Commission confirmed that adoption of the recent amendment to EN ISO 15223-1 (which changes the symbol for authorized representatives from “EC Rep” to “EU Rep”) will be addressed in the next Standards working Group meeting on 4 February 2026.
Finland Launches New Webpage on AI Regulation
Finland Competent Authority (FIMEA) has published a new AI resource page: HERE
It provides key definitions, compliance deadlines, and feedback on how to identify if your device is an AI system under the AI Act.
UK
MHRA Recording on New Annual Fees
The MHRA published a web recording on the upcoming fee changes: HERE
As a reminder, the MHRA advised they will begin charging annual registration maintenance fees starting April 2026, in order to help recover costs related to its post-market surveillance activities.
Team AB Guidance: How to Verify Certificates
Team NB published guidance on how to verify UKCA certificates: HERE
They pulled together a short list of links that allow anyone to check whether a certificate is valid, review the certificate status and scope, and confirm the issuing Approved Body.
MORE User Guide Updated
The MORE user guide was updated on 12 January 2026: HERE
It includes a new report reassignment functionality, allowing users to reassign reports to the appropriate manufacturer/responsible person within the MORE portal. The guidance notes: “This feature is particularly useful for transferring reports from your Workspace to your manufacturer organisation account once approval is granted.”
Switzerland
Swissmedic & Swiss Medtech on Vigilance
Swissmedic and Swiss MedTech issued a joint memo on vigilance reporting: HERE
It documents some key challenges expressed by manufacturers, including:
- Swissmedic’s requests are more stringent compared to other EU competent authorities
- Short response timelines (often 5 working days) for manufacturers to address Swissmedic’s inquiries
- Challenges to final non-reportable classifications without clear justification
- Repeated follow-up questions despite previous justifications provided by manufacturers
After meetings between Swissmedic and Swiss MedTech (and participants from MedTech Europe), the following (non-exhaustive) solutions were proposed.
- Short timelines: Swissmedic may request a 5-day (or shorter) timeline in urgent cases. However, manufacturers can request extensions when needed and Swissmedic may consider longer timelines if respected consistently.
- Reducing Follow-Up Questions: For non-reportable cases, manufacturers must provide a clear rationale why the incident was considered non-reportable. If necessary, provide a reference within the respective supporting document (e.g. chapter X of report Y) to ensure the scientific officer finds the respective information easily. For reportable cases, if a device is unavailable for investigation, document all efforts to retrieve it.
Please review the full memo for all solutions, and additional notes.
Swissmedic Updates swissdamed Business Rules
The new version is available: HERE
It now includes information on legacy devices throughout, including new sections addressing legacy devices.
Currently, swissdamed only allows registration of MDR/IVDR devices and systems/procedure packs. And does not accept MDD/AIMDD/IVDD devices. However, it appears Swissmedic is taking steps to add legacy device registration into the scope.
Upcoming swissdamed Webinar
Swissmedic is hosting a webinar about swissdamed: HERE
Topics:
- Device registration requirements and timelines
- How to register a medical device
- Managing registration updates and changes
- Linking to a medical device as an importer
- How to access instructions and technical information, and how to request support
- The swissdamed playground
- Q&A
Logistics:
- Takes place Thursday, 28 May 2026 at 14:00-16:00 (CEST)
- It is free
- It will be conducted in English
- Registration will close on 22 May 2026 (or once it’s fully booked)
Swissmedic Inspection of Importers
Swissmedic published results from its 2025 inspection of Swiss importers: HERE
The inspection included 30 importers, testing 232 product samples. Swissmedic noted deficiencies for 57% of importers inspected and 22% of reviewed devices. These include 30% incomplete importer information supplied with the device, 13% inadequate storage and transportation conditions, and 47% incomplete verification of devices.
Swissmedic to Reduce Staffing
Swissmedic announced it will reduce staffing: HERE
They will cut around 45 full-time equivalents over the next two years, in addition to reducing material costs by 6 million Swiss francs.
