Germany: Announcement from the Federal Ministry of Health regarding the transition until EUDAMED is available

On 26th May 2021, the Federal Ministry of Health issued the announcement regarding the transition to full EUDAMED functionality, as required in accordance with Section 97 MPDG; it was published on 28th May 2021 in the Federal Gazette. The regulations stipulate that registration with the EUDAMED module that is already available in advance is required for the SRN to be issued. Products are registered using the previous medical device information system (MPI/DIMDI database), which is now named DMIDS. Existing registrations will be transferred and should be updated by 26th May 2021. The specifications for registering serious incidents refer to the corresponding Federal Institute for Drugs and Medical Devices (BfArM) pages, which use forms included there, but currently (on 2nd June 2021) still refer to the German Medical Devices Act (MPG) and German Ordinance on Medical Device Safety Plans (MPSV).

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