Following a proposal by the European Commission, the EU states are considering postponing the entry into force of the EU Medical Devices Directive (MDR) by one year, which was originally scheduled to come into force on 26 May 2020. However, in view of the Covid 19 crisis, quick and unbureaucratic action is required, according to the health policy spokesman of the European People’s Party (EPP) in the European Parliament, Peter Liese, who now considers improvisation measures without months of testing procedures to be absolutely right and sensible in order to quickly start producing vital medical equipment such as respirators as well as protective equipment such as masks and surgical gowns. If it is helpful, even in companies not involved in the production, if necessary. Supply bottlenecks with medical devices must now be avoided. The necessary products must be available in sufficient numbers in times of the coronavirus pandemic, warns EU Health Commissioner Stella Kyriakides. The EU states and the European Parliament only have to agree to the European Commission’s proposal, which the Commission is currently working on at full speed. The change in standards will then lead to faster market access for medical products such as medical face masks, disinfection devices, surgical drapes and other medical products, which are now urgently needed for the optimal care of patients in the corona crisis. The rapidly established standards should then enable a faster and more cost-effective conformity assessment procedure to be carried out, in contrast to what was originally planned for 26 May this year. The new Medical Devices Ordinance, which will probably not come into force until 2021, contains changes with regard to uniform and more stringent criteria for the „notified bodies“, i.e. inspection bodies that monitor and control the assessment of the conformity of industrial products. The regulation also regulates the procedure for the approval of clinical trials of medical devices. The German Medical Technology Association (BVMed) also advocates postponing the new regulation.
