Contact

EUDAMED Registration

A mandatory requirement for manufacturers and representatives operating under EU MDR or IVDR, with defined timelines and ongoing maintenance obligatio
I need EUDAMED registration
  • EU Market, Medical Devices & IVDs

What are EUDAMED Registration services

Fixed Project Fee
UKALIA Ltd

EUDAMED — the European database for medical devices — is the central registration system for actors and devices under EU MDR (2017/745) and IVDR (2017/746). Registration is not optional. Manufacturers, Authorised Representatives, importers, and distributors must register within defined timelines, and records must be maintained and updated as devices and certificates change.

We manage EUDAMED registrations and ongoing data maintenance on behalf of manufacturers and their representatives. This includes the practical navigation of EUDAMED’s IT systems — which are frequently updated, technically demanding, and a source of significant delays for organisations that have not worked with them repeatedly.

Available as a standalone service or included within an EC-REP appointment.

What we do

  • Actor registration and SRN (Single Registration Number) management
  • Device registration: Basic UDI-DI, UDI-DI, and UDI-PI level entries
  • Certificate and Notified Body data entry and alignment
  • Periodic data review, update management, and record maintenance
  • Co-ordination across EUDAMED modules: Actors, Devices, Certificates, Vigilance, Market Surveillance
  • Practical guidance on navigating EUDAMED's IT systems and current database requirements

Who needs this?

  • Manufacturers with obligations under EU MDR (2017/745) or IVDR (2017/746)
  • EU Authorised Representatives who must register as an actor in EUDAMED
  • Importers and distributors with EUDAMED registration obligations
  • Manufacturers whose existing EUDAMED records are incomplete or incorrectly structured
  • Companies transitioning legacy devices to MDR/IVDR timelines who need EUDAMED records created or updated

What you'll receive

Verified EUDAMED actor registration. Structured device records. A maintained submission log. Practical operational support navigating the database — including the IT-side that is rarely addressed by advisors who have not used it at volume.
I need EUDAMED registration
Contact us