We help manufacturers and EU representatives prepare EUDAMED inputs and registration steps with the right prerequisites and clean data.
EUDAMED is the IT system established by MDR (EU) 2017/745 and IVDR (EU) 2017/746. It is intended to improve transparency and coordination of information regarding medical devices on the EU market.
EUDAMED rollout is staged. In the archived project materials, the key point is stated clearly: use of EUDAMED was not yet mandatory at that time, and certain modules were available for voluntary use.
Examples of modules mentioned as available for voluntary use:
Other modules (vigilance, clinical investigations/performance studies, market surveillance) were described as under development at that time.
You get a clear checklist, cleaned data inputs, and documented steps — so registration work is repeatable for future products and updates.
Note: EUDAMED requirements and availability evolve. We confirm current scope and modules before starting.
If your project requires CE marking, testing or conformity assessment, see our certification services.
If your workflow also requires certification planning, testing, EU AR setup, or a wider compliance route, Eucertify.eu is the better broad-scope intake point.