EUDAMED Goes Live: Navigating EU’s Device Database Requirements in2026

After years of development, the EU’s comprehensive medical device database (EUDAMED)

becomes mandatory in phases starting in early 2026. This marks a major step toward full

regulatory transparency across Europe and will impact every medical device manufacturer

selling into the EU.

EUDAMED consolidates multiple modules such as Actor registration, UDI and Device

registration, Certificates, and Market Surveillance into one centralized platform. By January

1, 2026, most of these modules will be fully operational and required for use, with the

Vigilance and Clinical Investigation modules following later in the year.

Manufacturers will be required to upload device identifiers, certificates, and post market

data into EUDAMED, linking product information directly to regulatory records. The intent

is to create a single, traceable system for all medical devices, improving safety and oversight while increasing public access to compliance data.

Companies should begin preparing their regulatory data now to ensure a smooth transition.

That means cleaning and organizing master data, assigning responsible EUDAMED actors,

and verifying that their internal systems can integrate with the database. Delaying

preparation could result in last minute compliance issues or disrupted market access.

EUDAMED represents a major step forward for the EU regulatory landscape. For companies, it is both a challenge and an opportunity to modernize data management and compliance systems.

If your organization needs guidance on preparing for EUDAMED’s rollout or aligning your

device data for submission, PRP Compliance can help you navigate the process efficiently

and confidently.