The Eudamed actor and device registrations will become mandatory next year (May?)*.
Failing to comply could jeopardize device conformity and disrupt the supply chain — Authorities and professional buyers (hospitals and retailers) will be checking whether devices are properly registered. Moreover, manufacturers and importers should not risk their visibility on the EU market. It is predicted that Eudamed will be the main source for the procurement of medical devices.
To prepare, manufacturers and Importers should implement new procedures and allocate resources for staff training on Eudamed registrations — a process often seen as complex and riddled with pitfalls. Even more, the registrations will not be just a one-off task; maintaining and updating records and registering new or modified devices will be an ongoing additional responsibility.
Having received calls for support and backed by decades of expert device registration experience, we are proud to introduce our
- End-to-End Eudamed Registration — from Actor registration through to device registration
- Data management & validation — ensuring the device data matches Eudamed requirements
- Regulatory consulting & monitoring — advising you on evolving Eudamed rules and best practices
- Ongoing maintenance & updates — the possibility for keeping registrations accurate over time
In short, we make the transition to the Eudamed era as smooth and worry-free as possible for you.
Whether or not you utilize our service – do not wait until the last minute. If you’d like a readiness check or want help planning your tailored approach, just contact us under
We are here to help you stay compliant and confident in your EU market access.
*some EU Member States already rely on Eudamed registrations.
