Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR) require manufacturers and Notified Bodies to submit certain information and documentation to the EU database EUDAMED (European Database on Medical Devices).
What is EUDAMED?
EUDAMED is a multi-purpose IT system developed by the EU Commission that will collate, process and disseminate information about medical devices/IVDs and related economic operators (such as manufacturers) to various stakeholders. EUDAMED aims to enhance overall transparency, including better access to information for the public and healthcare professionals, and enhance coordination between the different Member States in the EU. The system comprises of six modules related to:
- Actor registration
- Unique device identification (UDI) and device registration
- Notified Bodies and certificates
- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market surveillance
Amending Regulation (EU) 2024/1860 and EUDAMED gradual roll-out
On 9 July 2024, the amending Regulation (EU) 2024/1860 regarding gradual roll-out of EUDAMED was published in the Official Journal of the European Union (OJEU) with immediate effect.
The objective of the amending Regulation was to further mitigate the risk of shortages of medical devices on the market and for EUDAMED this meant:
- Implementing a gradual roll-out of the EUDAMED database, through making mandatory, the use of those EUDAMED modules that are already available for voluntary use once they are declared to be functional; instead of waiting for all the modules to become available and be declared functional before their mandated use.
The amending Regulation makes the use of the respective EUDAMED modules mandatory, after a specified transition period, once a notice is published in the Official Journal of the European Union (OJEU) that the relevant modules are functional and meet the specifications.
Publication of full functionality in the Official Journal of the European Union (OJEU)
On 27 November 2025 a notice was published in the Official Journal of the European Union (OJEU) for the Commission Decision (EU) 2025/2371, that the following four modules (out of six) have been declared functional and meet the specifications:
- Actor registration
- Unique device identification (UDI) and device registration
- Notified Bodies and certificates
- Market surveillance
There is a six-month transition period, after which use of the modules becomes mandatory from 28 May 2026
The information below summarizes the key dates and the specific requirements that apply to manufacturers and Notified Bodies as of those dates.
Deadlines relevant to Manufacturers for modules declared functional
27 November 2025
- Publication of the notice of module functionality in OJEU.
27 May 2026
- Actor registration: Economic operators must register themselves.
- UDI / Device registration: Manufacturers must register their Regulation devices in EUDAMED before placing them on the market*.
27 November 2026
- No later than 12 months after publication of the notice.
- UDI / Device registration: Manufacturers must complete registration of Regulation devices and legacy devices (unless the equivalent Regulation device is already registered) that were placed on the market before the mandatory use of the UDI/Dev module and that continue to be placed on the market also after the date.
* Note: for the purpose of the device registration in the UDI/Dev module, the term ‘placing on the market’ refers to the instance when the first product of a given device (e.g. identified with the same UDI-DI) is placed on the market.
Guidance on Actor registration and Device registration can be found on the EU Commission website EUDAMED Information Centre.
Deadlines relevant to Notified Bodies for modules declared functional
27 November 2025
- Publication of the notice of module functionality in OJEU.
27 May 2026
- No later than 6 months after publication of the notice
- Notified Bodies / Certificates: Notified Bodies shall start using EUDAMED to enter information regarding withdrawal and refusal of applications and regarding certificates (certificates issued, including amendments and supplements thereto, and suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates) on an on-going basis.
27 May 2027
- No later than 18 months after publication of the notice
- Notified Bodies / Certificates: Notified Bodies shall complete submitting all relevant certification and associated information on MDR/IVDR devices that manufacturers registered in EUDAMED and for which the NBs issued certificates prior to the module becoming mandatory.
Please refer to the Q&A document published by EU Commission for additional guidance on the gradual roll-out of EUDAMED in the context of (EU) 2024/1860.
Timelines for other EUDAMED modules not yet declared to be functional
As per the recent updates from the EU Commission, the Vigilance and Post-Market Surveillance module is expected to be declared functional in Q3 of 2026. The module covering Clinical investigations and performance studies is still under development. Details are in the updated roadmap published by the European Commission.
BSI’s plans for submitting application and certificate information into EUDAMED
BSI is working internally to comply with the applicable mandatory date of 28 May 2026 to submit application and certificate information into the Notified Bodies and Certificate module of EUDAMED. You can visit our webpage and our dedicated brochure to find out more about BSI’s plans for interfacing with EUDAMED.
