The Time Has Come!


Today, the transitional arrangement for the placing on the market and clinical trials of medical devices ends and the EU MDR 2017/745 must be applied throughout Europe, supplemented in Germany by the national requirements of the Medizinprodukterecht-Durchführungsgesetz (MPDG), which significantly exceeds the requirements of the EU MDR. In vitro diagnostic medical devices are still exempt. The regulatory requirements for clinical trials are increased in favor of patient safety-requirements that we at MEDIACC have already implemented for innovations.