EUDAMED delay announced!

The European Commission has officially announced a delay in the full implementation of the EUDAMED database. As mentioned in a previous post, this delay will affect all remaining phases of its development.

What has changed?

One of the major changes of this announcement concerns EUDAMED audit, which will happen twice. It will start with first 5 modules in the second quarter of 2024 and last until the end of the year.

The remaining module on Clinical Investigation/Performance Studies (CI/PS) will also start to be developed in the 2nd quarter of 2024 and last until the 3rd quarter of 2026. An audit of this module is expected between the end of 2026 and beginning of 2027.

The full functionality of EUDAMED is expected in the first quarter of 2027.

From then on, the following modules will become mandatory as of the fourth quarter of 2027 (6 months after the full functionality):

  • Actor Registration;
  • Vigilance;
  • Market Surveillance;
  • Clinical Investigation/Performance Studies (CI/PS);

Finally, the use of EUDAMED for devices and certificates registration will become mandatory by the second quarter of 2029 (24 months after the full functionality).

Source of image: European Commission

You can read more about this in our EUDAMED MDR and IVDR sections.

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