EUDAMED Express — registration preparation and support
Data preparation and support for actor registration (SRN) and up to 5 devices in EUDAMED. Data checklist, field mapping, expert verification and a final report — fixed price.
Prices in EUR, excluding VAT. VAT treatment will be specified in the individual proposal.
Opens your email app. The initial consultation is free.
When this service helps
- Medical device manufacturers (PL / CEE / EU)
- Importers and Authorized Representatives
- System / procedure pack producers
- Teams without in-house EUDAMED capacity
Inputs and scope boundaries
- The client needs their own EU Login account and LAA permissions to submit the application.
- National distribution without an EUDAMED role falls outside the scope.
- Approval timelines remain with the competent authority and are not guaranteed by this service.
Scope
- Actor + UDI data checklist (up to 5 devices)
- EUDAMED field mapping
- Expert verification by Alicja Załanowska
- Submission support (EU Login stays with the client)
- Final report + update guidance
FAQ
Do you guarantee SRN within X days?
No. Timelines depend on the competent authority. We prepare a complete, consistent submission and support the process — without promising CA decision dates.
Who clicks Submit in EUDAMED?
The client submits the application using their own EU Login account and LAA permissions. We prepare data, mapping and verification.
Devices beyond five?
+€350 per additional device (amendment). Larger packs are quoted individually.
Does EUDAMED Express include the PRRC role?
No. Actor registration is not the PRRC function (MDR Art. 15). AZ Regulatory does not take on that role.
Facing an EUDAMED deadline?
Write to us — we reply within 3 business days with a checklist and scope confirmation.
Discuss this service by email How to get an SRN in PolandAZ Regulatory is not a notified body, law firm or certifying authority. Advisory and documentation service only. SRN decisions belong to the competent authority. No guarantee of registration outcome or CE certification.