UK Consultation on CE Marking: MDD Extension, Indefinite Recognition, and International Reliance
16 February 2026
IMDRF Adverse Event Reporting (AER) Terms, Terminology, & Codes: Annexes Revised
3 March 2026Below is an overview of the February 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., the MHRA’s new consultation to indefinitely recognize CE Marking.
Europe Updates
From the European Commission
EUDAMED Onboarding Survey
The Commission released a new EUDAMED survey: HERE
It asks for feedback on the EUDAMED support materials available, and how confident users feel regarding EUDAMED.
‘Have your say’: Cybersecurity adopted act open for feedback
A feedback period is open for the newly adopted cybersecurity act: HERE
Stakeholders have until Monday 27 April 2026 to provide feedback. As well, the above link provides feedback already provided by others thus far.
High-level Conference on Medical Devices
The Commission is hosting a conference in Brussels entitled ‘Medical Devices: Innovation and patient safety’: HERE
It event will take place on 16 March 2026, in Brussels, Belgium, and will be livestreamed for those that registered for the event. Topics include enhanced predictability for conformity assessments, clinical evidence at EU level to support the regulatory framework (the key role of expert panels), breakthrough technologies, and the recent MDR/IVDR reform proposal.
From Team Notified Body (NB)
Letter on Cybersecurity in Medical Devices
Team-NB members endorsed a letter addressing the efforts to increase cybersecurity for medical devices in Europe: HERE
The letter notes that it welcomes revision of the cybersecurity act; however, Team-NB’s response also outlines several areas of caution, such as:
- Against granular technical rules which may quickly become outdated as cybersecurity evolves; recommend guidance and harmonized standards instead, as it allows for more adaptation to innovation.
- Extending the Cyber Resilience Act (CRA) to medical devices would add a disproportionate administrative burden in comparison to any cybersecurity gains.
- Decisions about device availability and patient safety should remain with MDR/IVDR governance bodies, and not with the European Union Agency for Cybersecurity (ENISA).
Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with Other Devices or Equipment
Team-NB’s position paper is available: HERE
The paper outlines expectations regarding what constitutes ‘adequate evidence’. For example:
- For closed systems with multiple instrument claims, a full performance evaluation is required for at least one combination, with demonstrated equivalence across the measurement range for the rest (or a full evaluation for each).
- For open systems, manufacturers must define critical equipment specifications and validate against at least one conforming instrument. Simply listing compatible instruments in the IFU is not enough.
It also advises that gaps in risk assessment, labeling clarity, or post-market surveillance focused on combinatorial performance will be flagged during technical documentation review.
MDR Technical Documentation Training
Team-NB is offering another MDR technical documentation training: HERE
It will be conducted remotely and takes place on 19 April 2026.
New Team-NB Member
Scarlet NB B.V. is the newest member of Team Notified Body: HERE
UK Updates
MHRA Webpage Guidance Updated
The MHRA updated multiple guidance webpages, including ‘Register medical devices to place on the market’ and ‘Regulation of medical devices in Northern Ireland’. Changes include:
- Regarding registration of custom-made devices being placed on the Northern Ireland market.
- EUDAMED requirements impacting Northern Ireland starting 28 May 2026.
- Medical device brand/trade names are now publicly identified in the public registration database (starting 23 February 2026).
Team Approved Body Position Paper on Annex II List A IVDs
Team Approved Body (Team-AB) published a new position paper related to Annex II, List A IVDs: HERE
There are currently no UK Reference Laboratories available to independently verify batches of Annex II List A IVDs (e.g., blood grouping reagents and HIV tests) under the UK MDR 2002 (“UKCA Marking”). This gap leaves the Approved Body (AB) to determine how to fulfill their batch verification obligations. This paper addresses that gap, proposing solutions such as where the AB witnesses batch testing at the manufacturer’s own premises, either during routine surveillance audits or dedicated visits.
It further notes that for devices dual-placed on the EU market under IVDD or IVDR, ABs may be able to leverage data from an affiliated EU Notified Body, provided a data-sharing agreement is in place and batch equivalence can be confirmed.
Switzerland Updates
On swissdamed
Machine to Machine (M2M) and Manual Entry Starting End of March
Swissmedic updated its swissdamed device registration webpage to note that M2M and manual entry functionality will be added by end of March.
As a reminder, on 28 May 2026, Swissmedic is hosting a training on swissdamed. While registration is now closed, Swissmedic notes that “the webinar will be recorded and will be publicly available on the Swissmedic website after the event”.
Registration Fee Timing Update
The FAQ on ‘device registration fee’ added the following sentence:
“According to current planning, the first invoicing of the registration fee, for those devices registered in swissdamed by the end of 2026, will take place in January 2027.”
To date, the fee amount has not been published. However, the current registration fee (non-swissdamed) is charged at CHF 300 per notification.
Alignment with EUDAMED Production Version 2.2.0
swissdamed has been updated to be compatible with the new technical version of EUDAMED’s data structure. This includes use of the updated EMDN codes.
Registration of Legacy Devices Now Possible
swissdamed now allows registration of legacy devices. Previously only regulation (MDR/IVDR) and system/procedure packs could be registered in swissdamed. Note that registration of any device is still voluntary. The UDI/Device module becomes mandatory starting 1 July 2026, followed by a six-month transition period.
Other Updates
Surveillance Report on Medical Devices for Wrinkle Treatment (‘Fillers’)
The report is available: HERE
It notes that the number of establishments inspected between 2024 and 2025 were roughly the same; however, that there have been no improvements in results year-over-year. In fact, found violations increased from 55% in 2024 to 80% in 2025. That said, “the inspections focused primarily on establishments that had raised suspicions, rather than on a random sample”.
Info Sheet on IVD Performance Studies Updated
The updated document is available: HERE
Changes include:
- Phone number in the footer of the title page updated.
- More detail added to section 2.7.1 letter c on the notification of non-substantial modifications.
- Wording of section 5.2.4, Annex A1 and A2 adjusted.
- Added section 5.2.6 on submission in case of confidentiality restrictions.
- Link to new MDCG guidance added to section 7.2.1(a) and more detailed instructions added to section 7.2.1(c).
- Section 9 on databanks used in Switzerland has been updated.
- More guidance on pregnancy has been added to Annex A4.
- In Annex A6, new information included under ‘Troubleshooting’ for submissions via the eMessage portal.
- Links, typos, formatting have been checked and updated.
IMDRF
Considerations for the selection of IMDRF Adverse Event Terminology
The IMDRF has published a new guidance document on adverse event terminology: HERE
It helps support correct code selection, including:
- Always select the lowest-level (most granular) code that accurately fits, not just a parent term.
- If a device malfunctions, code what actually went wrong, not the effect that drew your attention to it, e.g., “‘infusion device alarmed because the infusion tank was empty.’ In this scenario, the alarm is the normal function of the medical device and therefore is not coded as a malfunction.”
- Even on initial reports with limited information, placeholder codes like A26 (Insufficient Information) or D16 (Conclusion Not Yet Available) must be used rather than leaving fields empty.
- Normalizes updating codes in follow-up reports, as more information becomes available, i.e., codes can change as the investigation progresses.
- Provides example scenarios and code selection.
Playbook for Medical Device Regulatory Reliance Programs
The new document is available: HERE
It is primarily directed at regulatory authorities, with little immediate impact on manufacturers. It outlines the framework for regulatory authorities thinking about building reliance programs, including types of reliance.
