July 26, 2026
Starting November 28, 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 favorite filler brand has quietly disappeared from shelves.
Commission Decision (EU) 2025/2371, published in the Official Journal on November 27, 2025, made four EUDAMED modules (actor registration, UDI and device registration, notified bodies and certificates, and market surveillance) mandatory from May 28, 2026 for new devices. Legacy devices, meaning devices already on the market before that date but still being sold afterward, get a further six months: they must be registered in EUDAMED by November 28, 2026.
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.
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 suppliers if a favorite brand is behind schedule.
After November 28, 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.
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A new EU deadline means unregistered devices, including many dermal fillers, can no longer legally be sold after November 28, 2026. Check with your supplier.
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