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).
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 EUDAMED modules (out of six) have been declared functional:
- 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 these modules becomes mandatory from 28 May 2026.
For more information on timelines and requirements for manufacturers and Notified Bodies, please review our brochure.
What do you need to do as a Manufacturer?
Basic UDI-DI (BUDI) relationships to certificates.
EUDAMED introduces specific requirements governing the relationships between certificates, BUDIs, and SS(C)Ps, which may have a direct impact on how manufacturer's structure and maintain their technical documentation.
Certificate registration in EUDAMED may result in a link between a certificate and a BUDI. There can be multiple BUDIs associated with the same certificate (i.e. a single certificate can cover more than one BUDI), however, a BUDI can only be associated with a single Quality System annex certificate and a single Product annex certificate at a time. This means that if the same BUDI is referenced across multiple Product annex certificates, only one of those certificates can be successfully registered with that BUDI, potentially requiring consolidation or changes to certificate scopes.
Similarly, when registering an SS(C)P in EUDAMED, the associated BUDI(s) must be linked. However, each BUDI can only be linked to one SS(C)P.
In addition, EUDAMED permits only one intended purpose per BUDI. Where multiple intended purposes currently exist, manufacturers will need to review and separate these into a single, clearly defined intended purpose per BUDI prior to certificate submission to EUDAMED. This may affect manufacturers’ current BUDI assignments.
These requirements may necessitate a review and alignment of your existing technical documentation. Manufacturers are encouraged to assess their current use of BUDIs across certificates and SS(C)Ps, identify any overlaps or inconsistencies, and take proactive steps to rationalize documentation and certificate structures. Early preparation will help avoid delays in EUDAMED registration and ensure continued compliance with regulatory expectations.
Device registration
As a manufacturer it is important to begin registering your devices in EUDAMED as soon as possible, especially those devices that require a Product annex certificate and/or where the certificate is undergoing review, to help avoid delays in the subsequent registration of certificates. Timely device registration is a prerequisite for linking certificates and associated data within EUDAMED, and any delays at this stage may impact on the overall EUDAMED certificate submission process.
Please note the key regulatory milestones: EUDAMED becomes mandatory from 28 May 2026, with obligations applying to the registration of devices, certificates, and related information from this date. Early action will support a smoother transition and help ensure compliance with the upcoming requirements.
Resources
- Guidance on Actor registration and Device registration can be found on the EU Commission website EUDAMED Information Centre.
- 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.
- You can visit our webpage and dedicated brochure to find out more about BSI’s plans for interfacing with EUDAMED.
Summary
BSI strongly recommends manufacturers take proactive steps to register their devices within EUDAMED and comply with the other requirements that apply to them in relation to Actor and device registrations within EUDAMED.
We remain committed to ensuring transparency and compliance with regulatory requirements and will continue to inform you through this transition.
Yours sincerely,
Sofia Palm
Associate Head of Medical Devices Notified Body
