Overview

The implementing act for EUDAMED use has now formally been published in the Official Journal of the EU (OJEU): HERE

The European Comission (EC) additionally provided a further announcement about this publication: HERE

Timeline for Manufacturers

The OJEU publication triggers the following timeline:

In six months from today (28 MAY 2026): the implementing act formally comes into force. After this date, any device new to the European market must be registered in EUDAMED prior to marketing. Devices already on the market before this date will have a transition period.

In 12 months from today (28 NOVEMBER 2026): The transition period ends. All devices that were on the European market before 28 MAY 2026 must be registered in EUDAMED by this date. If not, the device will be out of MDR / IVDR compliance.

For more information timing, please see Question 7 in the the Commission’s Q&A on the Gradual Roll-Out of EUDAMED.

Note that it is the Notified Body’s responsibility to enter certificates into the Notified Bodies/Certificates module. And the Market Surveillance module is applicable to the national Competent Authorities. The EC published the below timeline images regarding these deadlines.

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Impacted EUDAMED Modules

The following sections (“modules”) of EUDAMED were published:

The remaining two EUDAMED modules will be published in the OJEU at a later date: Vigilance and Clinical Investigations/Performance Studies

Resources

To help companies get started, Casus has the following EUDAMED registration resources available:

Check back on Casus resources coming soon:

Questions about your specific registration requirements? Contact Casus for guidance.