With its new Regulation 2020/561, the EU has postponed the beginning of application of the Medical Devices Regulation 2017/745 for one year to May 26, 2021. The Regulation will only be be effective after this date. The beginning of validity of the IVD Regulation remains unaffected by May 26, 2022.
The European Association of Notified Bodies in the Medical Devices sector (Team NB) has now issued a statement on the new regulation. The Notified Bodies will continue to give the EU Commission their full support in the fight against the corona pandemic. They consider the postponement of the Medical Devices Regulation as an important tool to avoid bottlenecks with medical devices or to prevent their delayed availability. However, Team NB also notes that this will shorten the transition from the current regulations to the Medical Devices Regulation from 4 to 3 years. As a result, Team NB sees considerable additional work for the Notified Bodies. In its statement, Team NB recommends that manufacturers and other interested parties pursue their original plans as far as possible under these circumstances.
On the website of the European Association for Medical Devices of Notified Bodies - Team NB - you will find the Team-NB statement on MDR date of application postponement.