The European Commission recently announced last November that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. While the delay in EUDAMED certainly helps give us more time before we must submit information to the database including registrations, vigilance reports, clinical investigation information, PSURs, assigning Basic UDI-DI and SSCPs, it does not change the implementation dates for these activities.
This means actor registration, conformity assessments, product certification, device registration and supporting documentation are still required. We advise medical device manufacturers to continue investing in the implementation of EUDAMED to plan properly for M2M testing once new timelines are released by the Commission.
If you haven’t started EU preparation, take advantage of this postponement. Meeting the EU MDR compliance requirements still requires that companies automate the aggregation, validation and submission of their regulatory data.
We will continue to keep you updated as additional information is released.