First assessment of the German manufacturers of medical devices after the EU Medical Devices Regulation (MDR) came into force: Many problems still unsolved
A total of 378 medical technology companies participated. The results of the survey show that, from the manufacturers’ point of view, the MDR is not practicable in many places. For example, there are clear effects on the time and financial expenditure for market access – both for medical devices that have been tried and tested for many years as well as for innovative medical devices. In addition, there are operationally unsolvable obstacles for companies, for example, when notified bodies either do not react at all to their applications or reject them, or when clinical studies cannot be carried out for ethical reasons. The consequences are portfolio adjustments and even complete product discontinuations by companies as well as negative effects on the innovative strength of the industry and thus the availability of proven and innovative medical devices in the EU.
The study also contains some concrete proposals for solutions, which SPECTARIS, Medical Mountains and DIHK have coordinated among themselves.