AZ RegDocs

EUDAMED Express — SRN and device registration

Actor registration (SRN) plus up to 5 devices in EUDAMED. Data checklist, field mapping, expert verification and a final report — fixed price.

€2,500up to 5 devices · +€350/device beyond scope

3–5 business daysafter complete client data

Request the EUDAMED Express checklist WhatsApp

Who it is for

Medical device manufacturers (PL / CEE / EU)
Importers and Authorized Representatives
System / procedure pack producers
Teams without in-house EUDAMED capacity

Who it is not for

“Do it for us” without LAA / EU Login data
National distributors with no EUDAMED role
Expecting a guaranteed CA approval timeline

Scope

Actor + UDI data checklist (up to 5 devices)
EUDAMED field mapping
Expert verification by Alicja Załanowska
Submit 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?

Submit and EU Login remain with the client (LAA). 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.

Request checklist How to get an SRN in Poland

AZ 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.