EC Confirms 4 EUDAMED Modules Fully Functional
EC Confirms 4 EUDAMED Modules Fully Functional
Regulatory Affairs Medical Devices In Vitro Diagnostics
Thursday, 27 November 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 27 November 2025, the “ Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council” was published in the Official Journal of the EU (OJEU), confirming that four EUDAMED modules, Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance, are fully operational.
EC Confirms 4 EUDAMED Modules Fully Functional
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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. Device registration data becomes gradually public: - Devices requiring NB action become visible once linked and Master SSCP/SSP uploaded. - Devices not requiring NB action appear immediately upon successful manufacturer registration. - After these actions, EUDAMED is fully populated with UDI/Device and certificate data, along with Master SSCPs/SSPs where applicable. |
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
The final two modules, Post-Market Surveillance & Vigilance and Clinical Investigation & Performance Studies, are still in development and will become available when their use is required by law. There will be no period for voluntary use of these modules prior to their mandatory implementation.
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.
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