Since 28 May 2026, using EUDAMED, the European database on medical devices, is no longer a recommendation: it is mandatory. A second deadline is approaching, 27 November 2026, and it directly affects the materials you mill every day. Here is what changes, what does not, and what a laboratory should check right now.
What became mandatory on 28 May 2026
The European Commission declared four EUDAMED modules fully functional through Decision (EU) 2025/2371, published at the end of November 2025. Six months later, using them became mandatory:
- Actors: registration of economic operators, who receive a Single Registration Number (SRN);
- UDI and devices: registration of each device with its unique identifiers, the Basic UDI-DI and the UDI-DI;
- Notified bodies and certificates: the CE certificates issued under the regulation;
- Market surveillance.
In practice, a manufacturer must be registered as an actor, then register every new device before it is first placed on the European market. The certification body DNV puts it simply: a device that is not in EUDAMED should not be placed on the market.
27 November 2026, the deadline that concerns you
Devices already on the market before 28 May 2026, and still sold afterwards, get extra time. According to the Belgian Federal Agency for Medicines and Health Products (FAMHP), they must be registered in the UDI and devices module by 27 November 2026 at the latest. Notified bodies have until 28 May 2027 to upload the certificates issued before that date.
This is the deadline that affects your stock. The zirconia discs, lithium disilicate blocks or PMMA discs you buy today are, for the most part, products that have been sold for years. Their manufacturer must register them by the end of November.
Your custom-made prostheses stay outside EUDAMED
Good news for the laboratory: Regulation (EU) 2017/745 defines a custom-made device as a device made specifically in accordance with a written prescription from an authorised person, and intended for the sole use of a particular patient. That is exactly what a crown or a bridge coming out of your milling machine is.
Custom-made devices are excluded from registration in EUDAMED, and Article 27 of the regulation also excludes them from the Unique Device Identification system (UDI). You therefore do not need to register your crowns or assign them a UDI code.
The subtlety lies elsewhere: the crown is custom-made, but the disc it is milled from is not. It is a standard device, mass-produced, with a manufacturer, a CE marking and, from now on, a registration obligation.
What your supplier must already check
Article 14 of the regulation requires the distributor, before making a device available, to verify in particular:
- that the device bears the CE marking;
- that the EU declaration of conformity has been drawn up;
- that the labelling and instructions for use are supplied in the language of the country;
- that the manufacturer has assigned a UDI, where applicable.
These checks may be carried out by sampling. But they exist, and a serious supplier should be able to show you that it performs them.
Five checks to make before the end of November
- Ask for the UDI identifiers, Basic UDI-DI and UDI-DI, of every product you use: discs, blocks, resins.
- Look at the label: the UDI appears on the packaging, in plain text and as a machine-readable code.
- Look up the manufacturer on the public EUDAMED website, where its actor registration can be consulted.
- Keep the declaration of conformity and the instructions for use for each material.
- Record the lot and UDI of the disc in each case file: if a question ever arises about a restoration, you will find the material used straight away.
If a product still has no UDI as 27 November approaches, ask your supplier directly. It is better to plan a change of material than to discover the problem when you reorder.
For laboratories in Chile or Argentina, EUDAMED is not a local obligation. Even so, a material registered in the European database offers documented traceability that is worth asking for.
Where Dentev stands
This is the list we ask our own manufacturers for before listing a product: CE certificate, declaration of conformity, instructions for use and UDI identifiers. If you have a doubt about a material, write to us: we will send you the documents we hold.
Sources
- Osborne Clarke, “EU triggers mandatory Eudamed use for diagnostics and medtech from May 2026”, accessed 12 September 2026: osborneclarke.com/insights/eu-triggers-mandatory-eudamed-use-diagnostics-and-medtech-may-2026
- DNV, “EUDAMED mandatory use: what manufacturers need to know”, accessed 12 September 2026: dnv.com/article/eudamed-mandatory-use-what-manufacturers-need-to-know
- FAMHP (AFMPS), “EUDAMED : détail des obligations à partir du 28 mai 2026”, updated 10 December 2025: afmps.be/fr/news/eudamed_detail_des_obligations_a_partir_du_28_mai_2026
- ANSM, “Quelques informations sur Eudamed”, updated 31 July 2026: ansm.sante.fr
- MedTech Europe, “EUDAMED reaches a major milestone: mandatory use of the first four modules begins”, 4 June 2026: medtecheurope.org
- Regulation (EU) 2017/745 on medical devices, Articles 2, 14 and 27: eur-lex.europa.eu/eli/reg/2017/745/oj
