Update on EUDAMED state of play

The European Commission has released new minutes of the MDCG EUDAMED working group meeting of June 29, 2023.

Among other topics covered in the minutes, the European Commission indicated that the development of the EUDAMED platform would continue for at least one year to finalise the last module on Clinical Investigation/Performance Studies (CI/PS). This module and the Vigilance/Post-Market Surveillance module are expected to be developed once the first set of modules is finalised (expected at the end of 2023).

Moreover, the EUDAMED audit will start in the second half of 2024 and is expected to be completed by the end of the same year, lasting a maximum of 9 months.

Thus, we can expect a delay in the full functionality of the database, which impacts the existing timeline we presented in previous posts EUDAMED Delayed! from July 2022.

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

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