Two databases, two sets of numbers, no data link between them — and deadlines at the end of November and the end of December 2026. A practical guide for manufacturers selling in the EU and Switzerland.
Four EUDAMED modules — actors, UDI/devices, notified bodies & certificates, market surveillance — became mandatory on 28 May 2026. New devices must be registered before the first unit is sold; devices already on the market must be registered by late November 2026 (treat 27 November as the safe date). Switzerland runs its own database, swissdamed: device registration has been mandatory since 1 July 2026, with existing devices due by 31 December 2026 and a fee of CHF 200 for the first UDI-DI per year plus CHF 20 for each additional one. Data does not flow between the two systems.
Under Regulation (EU) 2024/1860, each EUDAMED module becomes mandatory six months after the Commission publishes a notice that it is functional. The notice for the first four modules was published on 27 November 2025 (Commission Decision (EU) 2025/2371).
| Obligation | Deadline |
|---|---|
| Actors, UDI/devices, NB & certificates, market surveillance | Mandatory from 28 May 2026 |
| New devices (first unit placed on the market on or after 28 May 2026) | Register before the first unit — no grace period |
| Devices already on the market before 28 May 2026 (MDR/IVDR and legacy) | By 28 November 2026 per the Commission timeline; several advisers read 27 November — use 27 November as the safe date |
| Certificates issued before 28 May 2026 | Notified bodies enter them by 28 May 2027 |
In Germany the national DMIDS registration stayed mandatory until 28 May 2026, and its data does not transfer to EUDAMED automatically.
One registration per device identifier covers all units: the UDI-DI under its Basic UDI-DI, or a EUDAMED DI/ID for legacy devices. A legacy device need not be registered if the same device is already registered under the MDR/IVDR, unless a vigilance event concerns only the legacy version. Devices no longer placed on the market need registering only if a vigilance or post-market action arises.
| Method | Best for |
|---|---|
| Web interface | Up to about 100 devices |
| XML bulk upload | About 100–1,000 devices, validated against the published schemas |
| Machine-to-machine (M2M) | Large portfolios; needs an eDelivery access point |
Prepare the data first: issuing-entity identifiers (GS1, HIBCC, ICCBBA or IFA), Basic UDI-DIs and UDI-DIs, EMDN nomenclature codes and, where relevant, the eIFU address.
Because the EU–Switzerland mutual recognition agreement was not updated for the MDR, Switzerland runs its own registration. An EU SRN does not count there, and EUDAMED data does not flow across.
The updated EU–CH device agreement signed in 2026 is not in force yet; plan as if the separate system stays for now. See Swiss pharma and medtech into Germany.
The actor, UDI/device, notified body and certificate, and market surveillance modules became mandatory on 28 May 2026, six months after the Commission notice of 27 November 2025.
Devices placed on the market before 28 May 2026 that continue to be sold must be registered within 12 months of the notice: 28 November 2026 per the Commission timeline. Treat 27 November 2026 as the safe date.
No. Switzerland uses swissdamed with its own CHRN numbers. Foreign manufacturers need a Swiss representative (CH-REP), and data must be uploaded separately; there is no interface between the systems.
Device registration has been mandatory since 1 July 2026. Devices already on the Swiss market must be registered by 31 December 2026, and devices with a vigilance event immediately.
CHF 200 for the first UDI-DI per manufacturer per year and CHF 20 for each additional one, capped at CHF 10,000 a year. Updates are free; foreign manufacturers are invoiced via their CH-REP.
We provide or coordinate the EU authorised representative and PRRC, prepare your UDI data for EUDAMED and swissdamed, and keep both registrations in sync.