The Commission proposal presented on December 16, 2025 to amend the (MDR and) IVDR is therefore generally viewed positively by the VDGH and the undersigned associations. It contains central and urgently needed measures to ensure the functionality of the European market, remove barriers to innovation and strengthen security of supply. Swift adoption is crucial in order to avoid further exacerbating existing bottlenecks and competitive disadvantages.
The VDGH has paid particular attention to the specific concerns of the diagnostics industry: In three position papers, the VDGH addresses concrete IVD-specific needs for adaptation and clarification of the Commission's proposal, which we recommend to the German government for its Council position. Firstly, a practicable orphan IVD framework is needed to keep diagnostics for rare diseases on the EU market in the long term. Secondly, terminological changes must not trigger disproportionate global re-authorization obligations if nothing has changed in the product itself. Thirdly, routine blood sampling in IVDR performance studies must be clearly classified as low-risk standard measures - otherwise there is a risk of unnecessary bureaucratic hurdles that slow down clinical research and weaken Europe as a study location.
