Entry into force of the Medical Device Regulation postponed

The European regulation for medical devices has been in force since May 2017 and should have been implemented by May 26, 2020. Due to the regulation, manufacturers would have had to implement a large number of new requirements by the deadline. At the end of last year, a corrigendum had already lifted the "arming" of the MDR for class Ir medical devices, which was actually planned for May 26, 2020. These products may now be placed on the market under the transitional provisions until May 2024 at the latest.

Due to the slow accreditation of notified bodies under the MDR, there were already fears of a bottleneck in processing new applications for conformity assessment procedures under the new legal regulations, and now there are also staff shortages due to the coronavirus pandemic at both manufacturers and notified bodies. For manufacturers, this postponement initially brings relief, but the requirements to be implemented should not be lost sight of despite the current crisis.

It is to be expected that the deadline for the Medical Devices EU Adaptation Act will now also be adjusted accordingly by the German legislator. In particular, this law was intended to introduce the Medical Devices Implementation Act (MPDG) on the previously planned deadline of 26.05.2020 in order to replace the Medical Devices Act (MPG) in force to date and to fill the remaining national regulatory options provided by the regulation. However, as the medical device directives will continue to apply for the time being, the previous regulations should also remain in place at national level.