EUDAMED / MDR & IVDR
EUDAMED stopped being voluntary on 28 May 2026. Devices already on the EU market before that date — including legacy devices still sold under transition-period certificates — have until 27 November 2026 to be registered, or lose their basis to stay on the market.
Last updated 6 September 2026
EUDAMED — the European Database on Medical Devices — moved from voluntary to mandatory. New medical devices and IVDs must now be registered before being placed on the EU market, and every actor in the supply chain has to be registered as an economic operator.
Source: European Commission MDCG guidance; see summaries at Obelis and MedEnvoy.
Devices already placed on the EU market before 28 May 2026 — including devices still being sold under certificates issued during the MDR/IVDR transition period — are not exempt. They have to be registered too, and the cut-off for that is 27 November 2026. Registration is sequential: actor and device data has to land first before certificate and UDI data can be linked to it, so the November deadline is closer than it looks once a backlog of legacy SKUs is involved.
Source: Registrar Corp's EUDAMED 2026 deadline guide; DNV's mandatory-use summary.
Not just manufacturers. Authorised representatives, importers, sponsors of clinical investigations and performance studies, and system/procedure pack producers all carry their own EUDAMED registration obligation. If your product touches the EU medical-device or IVD market under any of these roles, this is a compliance-calendar item now, not a future one.
EUDAMED (the European Database on Medical Devices) stopped being voluntary. From 28 May 2026 its four validated modules — Actor registration, UDI/Device registration, Notified Body and Certificates, and Market Surveillance — became mandatory. (The remaining Vigilance/post-market surveillance and clinical investigation modules have not yet been declared functional.) New medical devices and IVDs must be registered before being placed on the EU market.
It covers legacy devices — devices already placed on the EU market before 28 May 2026, including those still being sold under certificates issued during the MDR/IVDR transition period. Those devices must also be registered in EUDAMED, by 27 November 2026.
No. Every economic operator in the chain has an EUDAMED obligation: manufacturers, authorised representatives, importers, sponsors of clinical investigations and performance studies, and system/procedure pack producers.
An unregistered device loses its basis to be legally placed or kept on the EU market — the same practical effect as missing any other MDR/IVDR conformity step. Actor and device registration also has to happen before UDI/Device and Notified Body/Certificate data can be linked, so registration is the first domino, not a formality to sort out later.
EUDAMED registration touches actor data, device/UDI data, and certificate linkage across every SKU on the EU market — the kind of multi-step, multi-party programme that stalls when it's owned informally. We scope the registration gap across your legacy portfolio, coordinate with your notified body where certificates need linking, and manage the programme end to end.
Book a scoping call