With EUDAMED now mandatory across the EU, manufacturers, importers, and authorised representatives alike are wondering: who exactly needs to register, and by when?
Obelis breaks down the requirements clearly, so you know where your organisation stands.
What Are the EUDAMED Requirements?
EUDAMED is the European Database on Medical Devices. On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371, confirming that four EUDAMED modules became fully functional and triggering the countdown to mandatory use.
From 28 May 2026, EUDAMED is no longer optional or “voluntary”. Any obligation linked to one of the four modules must be now fulfilled in EUDAMED.
The following four modules must now be used:
- Actor Registration
- UDI/Device Registration
- Notified Bodies & Certificates
- Market Surveillance
Who Is Responsible for Registering in EUDAMED?
This is where many organisations still have gaps. The answer depends on your role in the supply chain.
Economic Operators must register their organisation in the Actor module before they are granted access to EUDAMED and can fulfil their respective obligations within the system.
More specifically:
- Manufacturers and producers of systems and procedure packs (SPPs) must first register as actors in EUDAMED before they can register their devices . They are responsible for ensuring that device registration is then completed in the UDI/Device Module.
- Non-EU manufacturers must appoint an EU Authorised Representative (EAR) before registering in EUDAMED. Unlike EU-based manufacturers, their actor registration must be verified by both the EAR and the relevant Competent Authority before it is approved. Once registration is successfully completed, an Actor ID / Single Registration Number (SRN) is issued. This SRN is mandatory for legally placing medical devices on the EU market.
- Importers have registration obligations as economic operators in the Actor module. However, they cannot register devices or SPPs – that responsibility stays with the manufacturer.
- Distributors may have indirect obligations depending on their role in the supply chain.
When Does Device Registration Need to Happen?
The key dates are legally binding:
- 28 May 2026 – Mandatory use of all four modules begins. New devices placed on the EU market from this date must be registered in the UDI/Device module before first placement. If the device is not registered in EUDAMED, it should not be placed on the market.
- 28 November 2026 – The final deadline to complete EUDAMED registration of legacy devices and Regulation devices, where the first individual unit has been placed on the market before 28 May 2026 and continues to be sold afterwards.
What About the EUDAMED Delay?
There has been considerable discussion around delays in EUDAMED’s rollout over the years. Those delays are now behind us. EUDAMED has been introduced in phases, with each module only becoming legally mandatory after the European Commission formally declares it functional in the Official Journal of the EU. That declaration has been made for the four core modules, and enforcement is underway.
Vigilance and Post-Market Surveillance functionality is expected later (Q3 2026), while some modules remain under development.
Data Consistency Is Non-Negotiable
One detail that catches organisations off guard: all EUDAMED data must match, including technical documentation, labelling, Instructions for Use, and certificates issued by the Notified Body.
Sources
European Commission (2025). EUDAMED Information Centre – Actor Module: Introduction. European Commission – EUDAMED Help. Retrieved on 20 May 2026 from https://webgate.ec.europa.eu/eudamed-help/en/actor/topics-by-actor/all-actors/introduction.html
DNV (2026). EUDAMED mandatory use: What manufacturers need to know. DNV – Medical Devices Insights. Retrieved on 20 May 2026 from https://www.dnv.com/article/eudamed-mandatory-use-what-manufacturers-need-to-know/
Registrar Corp (2026). EUDAMED 2026 Registration. Registrar Corp – Medical Device Registration Blog. Retrieved on 20 May 2026 from https://www.registrarcorp.com/blog/medical-devices/medical-device-registration/eudamed-2026-registration/