Research with medical devices: MDR implementation postponed until 26 MAY 2021

Due to the coronavirus crisis, the European Parliament has decided to postpone the entry into force of the European Medical Device Regulation (MDR), EU no. 2017/745, for a year, until 26 May 2021.

The CCMO is taking stock of the consequences of this for clinical research with medical devices with regard to MRECs and the CCMO. The CCMO will provide more information on this topic soon via english.ccmo.nl.  In the meantime the MREC will review research files according to its existing procedure and based on the current requirements under the Medical Devices Directive (MDD).