EUDAMED device registration is now mandatory: what manufacturers need to do
The next phase of the European Medical Device Regulation (EU) 2017/745 is now in effect. As of 28 May 2026, EUDAMED device registration has become mandatory for new medical devices placed on the EU market. Manufacturers must ensure that their product information is correctly registered and maintained in the European database.
For devices already placed on the market before this date, a six month transition period applies to complete the required registrations. This deadline is approaching quickly, and manufacturers should act now to prevent compliance issues and potential market access disruptions.
What does this include?
EUDAMED obligations include the registration of:
- Basic UDI-DIs
- UDI-DIs
- device information
- relevant regulatory data
Missing, incomplete, or incorrect data may lead to regulatory challenges. That is why EUDAMED registration is not just a submission exercise. It also requires careful preparation, validation, and consistency across your technical and regulatory documentation.
Why manufacturers should act now
For many manufacturers, EUDAMED registration affects multiple data sources and internal stakeholders. Basic UDI-DI and UDI-DI structures must be set up correctly, registration data must be complete, and all information must align with technical documentation, Declarations of Conformity, certificates, and labelling.
With the transition period already running for devices placed on the market before 26 May 2026, waiting too long may create unnecessary pressure and increase the risk of delays, inconsistencies, or compliance gaps.
How we support your registration process
We support medical device companies throughout the EUDAMED registration process, from data preparation and verification to successful submission.
Our regulatory experts can assist with:
- reviewing your EUDAMED readiness and registration status
- setting up and verifying Basic UDI-DI and UDI-DI structures
- preparing and validating device registration data
- supporting manual submissions and bulk XML uploads
- checking consistency with technical documentation, Declarations of Conformity, certificates, and labelling
- providing guidance for manufacturers, authorized representatives, importers, and other economic operators
Whether you are registering new devices or completing existing registrations
Whether you need to register new devices, complete existing product registrations before the transition deadline, or verify submitted data, our specialists are ready to help.
EUDAMED device registration is now a mandatory part of MDR compliance. Acting early helps reduce risk, avoid unnecessary disruption, and keep your market access on track.
Need support with your EUDAMED registrations? Contact us today for more information or request a quotation. Let our experts help you achieve and maintain MDR compliance.
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