EUDAMED, the European database on medical devices, stopped being optional on 28 May 2026. From that date the use of its first four modules became mandatory under the MDR:
- Actor registration: manufacturers, Authorised Representatives, importers and system/procedure pack producers.
- UDI/Device registration: devices and their UDI data.
- Notified Bodies and Certificates.
- Market Surveillance.
The European Commission published the notice confirming these modules were functional in late 2025, which started the transition periods now running out.
The date that matters now: 28 November 2026
Devices that were placed on the market before 28 May 2026 and are still being made available after that date must be registered in the UDI/Device module by 28 November 2026.
Two practical points make this less daunting than it sounds:
- One registration covers all units that share the same UDI device identifier (UDI-DI), whenever each unit was placed on the market.
- Devices with no units left on the market from 28 May 2026 generally don’t need to be registered, unless post-market surveillance or vigilance activity later requires it.
For devices placed on the market on or after 28 May 2026, there is no transition period: under Article 29 of the MDR the manufacturer must register the device (including its Basic UDI-DI) before placing it on the market.
Notified bodies have a separate, later deadline: MDR and IVDR certificates issued before mandatory use must be registered by 28 May 2027.
Who does what
Registration is the manufacturer’s responsibility, but the other economic operators in your supply chain have to check it.
| Role | What the MDR asks of them in relation to registration |
|---|---|
| Manufacturer | Registers as an actor (obtaining a Single Registration Number, SRN) and registers its devices and UDI data. |
| Authorised Representative | Meets its own actor-registration obligations and verifies that the manufacturer has met its registration obligations (Article 11(3)(c)). |
| Importer | Verifies that the device is registered in the electronic system and adds its own details to that registration (Article 13(4)). |
In other words: if your registration isn’t complete, your importer can’t do its job properly, and your Authorised Representative is required to notice.
A short checklist for non-EU manufacturers
- Confirm your actor registration and SRN are active, and that your Authorised Representative is correctly linked to your actor record.
- List every device family still being made available in the EU, and check each Basic UDI-DI and UDI-DI is registered, or scheduled to be before 28 November 2026.
- Check that the importer for each route to market has added its details to your device registrations.
- Make sure your labelling, declaration of conformity and EUDAMED data agree on who your Authorised Representative and importer are.
- Decide who owns EUDAMED data updates going forward. Registration isn’t a one-off: changes to devices and economic operators have to be kept current.
How we can help
As a EUDAMED-registered importer, MD QMS SRL has to verify your registration before placing your devices on the market, so we check it with you as part of onboarding. If you need a wider review of your EUDAMED data and economic-operator roles, our UK sister company MD QMS Ltd. runs a fixed-price EUDAMED and market-access check.
This article summarises the position as of September 2026 and is not legal advice. Check the current text of Regulation (EU) 2017/745 and Commission guidance for your devices.