On 27 November 2025, the European Commission confirmed that EUDAMED’s first modules are fully functional[GP1] . Mandatory use begins on 28 May 2026.
EUDAMED functionality notice published: what it means
Commission Decision (EU) 2025/2371 [GP1] confirms that four modules of the European database are fully functional and meet their legal specifications:
- Actor Registration
- UDI/Device Registration
- Notified bodies and Certificates
- Market Surveillance
As a result, a six-month transition period has begun. The mandatory use of these modules starts on 28 May 2026.
What changes from 28 May 2026?
From 28 May 2026, the use of the four EUDAMED modules listed above becomes mandatory under the MDR and IVDR. This means that all relevant regulatory activities falling under these modules must be conducted exclusively through EUDAMED.
The remaining two modules (Vigilance and Clinical Investigations) will become mandatory once they are also officially declared functional. Unlike the first four modules, there will be no voluntary use phase prior to their mandatory application.
EUDAMED registration deadlines: actors, devices, and certificates
Actor registration deadline
TAll economic operators – manufacturers, authorised representative, sponsors of clinical investigations and performance studies, importers, system and procedure pack producers – must be registered in EUDAMED by 28 May 2026[GP1] .
Each actor has to:
- Register via the Actor module
- Be verified by the authorised representative (if applicable) and by the competent authority
- Obtain a Single Registration Number (SRN)
Device registration deadlines
For device registration, two deadlines apply, depending on when the device is placed on the market.
28 May 2026: new devices must be registered in the UDI/Device module before they are placed on the EU market.
Devices which were placed on the market before 28 May 2026 must be registered by 28 November 2026 [GP1] (12 months after the notice).
Next steps for medical device manufacturers
Medical device manufacturers should begin by verifying whether their organisation and devices are already registered in EUDAMED. If not, it is essential to initiate actor registration to obtain the required Single Registration Number (SRN).
A structured review of the device portfolio will help identify which products require new registration or retrospective entry. Manufacturers should also confirm with their notified body the timing and process for certificate uploads.
Where gaps are identified, businesses should coordinate internally or with their EU authorised representative to ensure timely data submission. This includes preparing technical documentation, UDI information, and certificate details in line with EUDAMED requirements.
Looking to register your company or devices in EUDAMED? Contact Obelis to get started with expert support.
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References:
European Commission (2025). Overview: EUDAMED, the European Database on Medical Devices. European Commission – Public Health. Retrieved on 11 December 2025 from [GP1] https://health.ec.europa.eu/medical-devices-eudamed/overview_en.
EUR-Lex. (2025). 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 (OJ L 2025/2371). Retrieved on 11 December 2025.
Giulia Maria Trapanese
Regulatory Intelligence & Innovation Department
19/12/2025
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