The European Commission recently announced that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. Given this postponement, we now have the opportunity, and sufficient time, to properly prepare for implementing M2M data exchange with EUDAMED.
Many device manufacturers shared their concern with us that the EU Commission’s 26 May 2020 deadline was a near impossibility. This is no longer the case! We now have a realistic chance of meeting this requirement successfully.
Please note that while the data exchange deadline may be delayed, the MDR deadlines for 26 May 2020 still apply. This means actor registration, conformity assessments, product certification, device registration and supporting documentation are still required. This includes assigning Basic UDI-DI and SSCPs, etc. 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.