26 July 2026
From 28 November 2026, medical devices that are not registered in the EU's EUDAMED database, including many dermal fillers and aesthetic devices, will have no legal basis for sale in the EU. If your clinic buys product from an EU-based supplier or distributor, it is worth confirming now that they are on track, rather than finding out in November that a favourite filler brand has quietly disappeared from shelves.
What is changing on 28 November 2026
Commission Decision (EU) 2025/2371, published in the Official Journal on 27 November 2025, made four EUDAMED modules (actor registration, UDI and device registration, notified bodies and certificates, and market surveillance) mandatory from 28 May 2026 for new devices. Legacy devices, meaning devices already on the market before that date but still being sold afterwards, get a further six months: they must be registered in EUDAMED by 28 November 2026.
Why this reaches dermal fillers and aesthetic devices
Hyaluronic acid and other dermal fillers used purely for aesthetic purposes are classified as Annex XVI, Group 3 products under EU Medical Device Regulation 2017/745, and sit under Common Specifications (EU) 2022/2346. That brings them into the same regime as other medical devices: CE marking, a Unique Device Identifier, and EUDAMED registration, alongside ongoing post-market surveillance. Other aesthetic technology, such as some energy-based devices, can fall under the same Annex.
What to check with your supplier now
Ask your filler or device manufacturer, or your distributor, whether the specific product you use is already registered in EUDAMED, and ask for confirmation in writing. Confirm the CE marking and Unique Device Identifier are current, and keep that documentation on file alongside your other compliance records. Doing this now, four months ahead of the deadline, gives you time to switch supplier if a favourite brand is behind schedule.
What happens if a device misses the deadline
After 28 November 2026, a device without a valid EUDAMED record has no legal basis for continued sale in the EU, and national authorities can act against products placed on the market without one. This is an EU requirement rather than a UK one, since the UK regulates devices separately through the MHRA, but many suppliers serve both markets from the same production and distribution chain, so a gap can still disrupt stock for a UK clinic.
Common questions
- What is the EUDAMED deadline for medical devices?
- Commission Decision (EU) 2025/2371 requires legacy medical devices, those already on the market before 28 May 2026 but still sold afterwards, to be registered in the EUDAMED database by 28 November 2026, or lose their legal basis for sale in the EU.
- Are dermal fillers covered by the EUDAMED deadline?
- Yes. Hyaluronic acid and other fillers sold for aesthetic purposes are classified as Annex XVI, Group 3 devices under EU MDR 2017/745, which brings them under the same CE marking, Unique Device Identifier and EUDAMED registration requirements as other medical devices.
- Does the EUDAMED deadline apply to UK clinics?
- EUDAMED and its deadlines are an EU requirement; the UK regulates devices separately through the MHRA. UK clinics sourcing product from EU suppliers may still want to check compliance status, since it can affect availability across a shared European supply chain.
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