The European database on medical devices, known as EUDAMED, has been developed in phases since the EU MDR entered into application in 2021. After several delays, the European Commission confirmed that four core EUDAMED modules will become mandatory on May 28, 2026. From that date, manufacturers who have not registered in EUDAMED and obtained a valid Single Registration Number (SRN) will be unable to lawfully place new devices on the EU market. This deadline is firm, and industry stakeholders have been advised to treat it as immovable.
Which EUDAMED Modules Become Mandatory in May 2026
EUDAMED is structured around six functional modules. The four modules becoming mandatory on May 28, 2026 are:
- Actor Registration (Module 1): All economic operators - manufacturers, authorized representatives, importers, and distributors - must register and obtain an SRN
- UDI and Device Registration (Module 2): Devices must be registered with their UDI-DI, basic UDI-DI, and associated device information before placing on the market
- Notified Body and Certificate Registration (Module 3): Certificates issued by notified bodies must be uploaded and linked to device registrations
- Clinical Investigations and Performance Studies (Module 4): Sponsors of clinical investigations under EU MDR must submit and manage study data through EUDAMED
The SRN Requirement and Its Market Access Implications
The SRN is the unique identifier assigned to each economic operator upon successful EUDAMED registration. Under EU MDR Article 31, the SRN must appear on declarations of conformity and certain labeling elements from the mandatory date. Authorized Representatives (ARs) acting on behalf of non-EU manufacturers must also have a valid SRN, and manufacturers must ensure their AR's EUDAMED registration is current. Without a valid SRN chain covering manufacturer, AR, and device registration, distributors and importers in EU member states should not accept goods for market placement.
Common Registration Pitfalls to Avoid
EUDAMED registration has presented practical challenges for many manufacturers. Account creation requires an EU Login credential linked to a verified organizational account, and the verification process can take several weeks when national competent authorities must confirm the registration. Common errors include mismatched information between the EUDAMED actor registration and the authorized representative agreement, incorrect GMDN code assignments, and UDI-DI data that does not match what has been submitted to GUDID or other national databases. Manufacturers should begin or verify their registration immediately, as competent authority processing queues typically increase significantly in the weeks before major deadlines.
Action Steps for Manufacturers Before May 28, 2026
The steps below represent the minimum actions required to be EUDAMED-compliant by the mandatory date:
- Verify that your EU Login account and organizational EUDAMED account are active and verified by your national competent authority
- Confirm your Authorized Representative's EUDAMED registration is valid and linked to your manufacturer record
- Complete UDI-DI registration for all devices currently on the EU market or planned for launch before May 28
- Upload all current notified body certificates and confirm the certificate linkage to device registrations is accurate
- Train internal regulatory and quality teams on EUDAMED data maintenance obligations, which are ongoing after the mandatory date
Ongoing Obligations After the Mandatory Date
EUDAMED compliance is not a one-time registration event. Manufacturers must update device registration data within prescribed timeframes when device information changes, and the post-market surveillance and vigilance modules will add further ongoing obligations as they reach mandatory status. Building internal workflows to manage EUDAMED updates as part of routine change control and post-market processes is essential for sustained compliance.
Frequently Asked Questions
Which EUDAMED modules become mandatory on May 28, 2026?
Four modules become mandatory: Actor Registration (Module 1), requiring all economic operators to register and obtain a Single Registration Number; UDI and Device Registration (Module 2), requiring device registration before market placement; Notified Body and Certificate Registration (Module 3), requiring upload of notified body certificates linked to device registrations; and Clinical Investigations and Performance Studies (Module 4), requiring sponsors to submit and manage study data through EUDAMED.
What happens if a manufacturer does not have a valid SRN by May 28, 2026?
Without a valid Single Registration Number (SRN) from EUDAMED, manufacturers cannot lawfully place new devices on the EU market. The SRN must appear on declarations of conformity and certain labeling elements from the mandatory date. Distributors and importers in EU member states should not accept goods for market placement where the SRN chain covering manufacturer, authorized representative, and device registration is incomplete.
What are the most common EUDAMED registration mistakes manufacturers make?
Common errors include mismatched information between the EUDAMED actor registration and the authorized representative agreement, incorrect GMDN code assignments, and UDI-DI data that does not match what has been submitted to GUDID or other national databases. Account creation requires an EU Login credential linked to a verified organizational account, and national competent authority verification can take several weeks - a timeline that compresses significantly as deadlines approach.