In view of the current COVID-19 pandemic, the EU Parliament has postponed the start of the EU Medical Devices Regulation (MDR) until 26 May 2021. This means that medical devices can still be marketed for another year under the previous regulations.
The Medical Devices Regulation was supposed to come into force on 26 May of this year. Among other things, it lays down uniform criteria for testing bodies, the so-called Notified Bodies, for the approval of medical devices and regulates the procedure for the approval of clinical trials of medical devices.
Already in March, the EU Commission had advocated postponing the start of the regulation in order to avoid supply bottlenecks with medical devices during the corona crisis.