The implementation of the EUDAMED Vigilance and Post-Market Surveillance module appears likely to be delayed beyond the previously anticipated Q2 2027 timeline.
Advena understands that, following inconclusive audit results, a further audit will be required before the module can be formally declared functional and the process towards mandatory use can proceed. On this basis, mandatory use is not expected to begin before 2028, although the precise implementation date has yet to be confirmed.
Manufacturers should therefore take this revised timeline into account when planning their regulatory activities. However, the delay does not affect existing vigilance and post-market surveillance obligations under the MDR and IVDR, which remain applicable.
Advena will continue to monitor developments and provide further updates as the implementation timeline becomes clearer.
