What is EUDAMED?
- The European Database on Medical Devices (EUDAMED) is an information system established by Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and developed by the European Commission.
- It enhances transparency and the harmonisation of information on medical devices available on the EU market.
- EUDAMED is an online portal for the exchange of information between economic operators, national competent authorities, notified bodies and the European Commission (EC). It also provides improved access to information for the public and healthcare professionals.
Information on EUDAMED on European Commission’s website can be accessed here.
On 26 November 2021, the was adopted. This Regulation is binding in its entirety and directly applicable in all EU Member States.
On 13 June 2024, Regulation (EU) 2024/1860, amending the MDR and the IVDR was adopted.It introduced a gradual roll-out of EUDAMED, based on the progressive verification of the functionality of individual EUDAMED modules. The mandatory use of each module starts six months after the module has been declared functional following an independent audit and after publication of a corresponding notice by the Commission in the Official Journal of the European Union. The transitional provisions allow Member States to introduce national measures during the transitional period. Further information is available in the Commission’s Q&A.
On 27 November 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 was published in the Official Journal of the European Union. By this Decision, the European Commission declared four EUDAMED modules to be fully functional and compliant with the functional specifications referred to in Article 34(1) of Regulation (EU) 2017/745.
In accordance with Regulation (EU) 2024/1860, the mandatory use of these modules will apply from 28 May 2026.
EUDAMED modules timeline
How is EUDAMED structured?
- Actor registration (mandatory use from 28 May 2026)
- UDI/Devices registration (mandatory use from 28 May 2026)
- Notified Bodies and Certificates (mandatory use from 28 May 2026)
- Clinical Investigations and performance studies (under development by the European Commission)
- Vigilance and post-market surveillance (under development by the European Commission)
- Market surveillance (mandatory use from 28 May 2026)
Actor Registration Module
- manufacturers,
- authorised representatives,
- importers,
- systems and procedure packs producers.
- for manufacturers, manufacturer’s authorised representative and systems and procedure packs producers – HERE
- for importers – HERE
Registration in the national Register of economic operators established in the Republic of Slovenia that carry out activities in the field of medical devices is necessary for the confirmation of the economic operator in EUDAMED. After the verification of information by JAZMP in accordance with Article 31 of the Regulation (EU) 2017/745, the economic operator is assigned a SRN through EUDAMED.
The Actor Registration Module was declared functional by Commission Decision (EU) 2025/2371. Its use will be mandatory from 28 May 2026.
UDI/Devices Registration Module
At the end of 2021, the UDI/Devices Registration Module (UDI/DEV Module) was made available by the EC.
The MDR and the IVDR Regulations introduce an EU system for the identification of devices based on a Unique Device Identification (UDI), improving traceability of medical devices.
The module was declared functional by Commission Decision (EU) 2025/2371. In accordance with Regulation (EU) 2024/1860, registration of devices in this module will be mandatory from 28 May 2026.
Clarifications and instructions for the registration of devices in the UDI registration module are available here.
Notified Bodies and Certificates Module
The Notified Bodies and Certificates Module (NB/CRF Module) is available and has been declared functional.
Under the MDR and IVDR, notified bodies are required to enter into EUDAMED all information on issued certificates, including amendments and supplements, as well as certificates that are suspended, reinstated, withdrawn or refused, together with any associated restrictions. Information on certificates entered in EUDAMED will be publicly accessible.
In accordance with Regulation (EU) 2024/1860, registration of certificates in EUDAMED will be mandatory from 28 May 2026.Clarifications and instructions regarding the Notified Bodies and Certificates Module are available here.
