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This announcement represents a key milestone in the rollout of the MDR/IVDR framework and officially starts the legal compliance timelines for these modules.
Key dates in the EUDAMED compliance timeline
| Date | Event | Key points |
| 27 Nov 2025 (“Day 0”) | Commission notice published in OJEU confirming functionality of 4 EUDAMED modules: Actors, UDI/Devices, Notified Bodies & Certificates, Market Surveillance | Modules are confirmed compliant with legal requirements; start of countdown to mandatory use. |
| 28 May 2026 (Day 0 + 6 months) | Mandatory use begins for the four modules | Registration moves from national systems to central EUDAMED; all new devices and system/procedure packs must be registered before placing on the EU market. |
| 28 Nov 2026 (Day 0 + 12 months) | Transition period ends for pre-existing devices | Devices on the market before 28 May 2026 must be registered by this date. Exceptions: legacy devices already registered, custom-made devices, and devices for clinical investigations/performance studies. |
| 28 May 2027 (Day 0 + 18 months) | Notified Bodies complete certificate & Master SSCP registration |
Notified Bodies must enter issued certificates and upload Master SSCPs/SSPs for applicable devices.
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Who enters data in each EUDAMED module?
- Actors: Manufacturers, authorised representatives, importers, system/procedure pack producers
- UDI/Devices: Manufacturers, system/procedure pack producers
- Notified Bodies & Certificates: Notified Bodies
- Market Surveillance: Competent Authorities
What does this mean for you?
For legal manufacturers of medical devices or IVDs, the publication of Commission Decision (EU) 2025/2371 confirms that four EUDAMED modules, Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance, are fully operational.
You should now:
- Make sure your Actor registration in EUDAMED is complete and up to date.
- Prepare to register all new devices and system or procedure packs in the UDI/Device module before placing them on the EU market from 28 May 2026.
- Understand the requirements for Notified Bodies and certificates, as well as market surveillance obligations.
- Check internal processes and assign responsibilities to meet the upcoming mandatory use deadlines.
