Figure 1: The European and national legal framework for IVD manufactured in-house. The IVDD will be completely replaced by the IVDR on May 26, 2022. In contrast to the IVDD, the IVDR is directly applicable to all addressees and contains requirements for IVD manufactured in-house. The Medical Devices Act (MPG) will gradually be replaced by the Medical Device Law Implementation Act (MPDG), which will only contain regulations that are within the scope of the national legislator. Based on current knowledge, the Medical Devices Operator Ordinance (MPBetreibV) will not be amended for the IVD sector, which will continue to refer to the RiliBÄK. The list of national regulations in the figure is not exhaustive.