EUDAMED and UDI

Key Steps for EUDAMED and UDI-DI Registration

Reliable registration begins with verified economic-operator details and continues with a consistent device identity and data set.

TENA Consulting5-minute read

Actor registration and SRN

Manufacturers, authorised representatives and importers should determine their role, prepare verified organisation details and complete the applicable actor registration process before device data submission.

Basic UDI-DI and UDI-DI

The Basic UDI-DI identifies a device family in regulatory documentation and is not placed on the label. The UDI-DI identifies a specific device and packaging level. Product names, models, risk class and certificate data must be consistent across records.

Data preparation

Confirm the intended purpose, nomenclature code, device status, packaging hierarchy and applicable certificate information. Establish change control so updates to labels, certificates and product configurations are reflected in regulatory records.

Important: Mandatory-use dates and transitional arrangements can change. Confirm the European Commission’s current EUDAMED implementation timetable for every project.

Official sources

European Commission — EUDAMED
European Commission — UDI

Prepare your registration data with confidence

We support actor and device registration data review.

Contact us