EUDAMED
What Manufacturers Must Do Now
Obligations, deadlines, and practical insights on the European medical device database — explained by DQS, your Notified Body NB 0297.
What this guide covers
Four chapters covering all practical aspects of EUDAMED registration — structured and drawn directly from our conformity assessment experience.
EUDAMED in Brief
What the database is, which six modules exist, which four are already mandatory - and what the most common misconceptions are.
Your Obligations as a Manufacturer
Actor registration, UDI/products, deadlines, vigilance, and market surveillance - what you need to do and by when.
The Role of the Notified Body
What DQS registers in EUDAMED - and where your product data is a prerequisite for our notification. Why your data must come first.
Practice: Tips, Mistakes, Checklist
Six practical tips, five common mistakes that delay procedures, and an eight-point checklist for your internal preparation.
The Four Deadlines That Matter
27.11.2025
Decision published
Start of the 6-month countdown — four modules declared operational.
Mandatory use begins
New MDR devices must be registered before being placed on the market. No SRN, no market access.
Existing devices
Devices placed on the market before 28 May 2026 that continue to be distributed must be registered.
Legacy certificates
All certificates issued before 28 May 2026 must be entered in EUDAMED by the Notified Body.
The Five Most Common Mistakes
and How to Avoid Them
Only new products registered
Work from the certificate scope, not from the change. All products listed on the certificate must be in EUDAMED - not just the newly added ones.
Wrong certificate type selected
DQS issues certificates under Annex IX Chapter I and II. If "Annex X" is entered, the status remains stuck on "submitted".
Updated SSCP version submitted
Only the version submitted and approved during the review process is uploaded - not a subsequently updated, unreviewed version.
Basic UDI-DI changed independently
Notify DQS first, have the registration discarded, then make the change — not the other way around. Otherwise inconsistent data records will result.
CECP without pre-registered Basic UDI-DI
The clinical evaluation consultation procedure cannot be initiated until the Basic UDI-DI has been registered in EUDAMED.