On May 26, 2021, the Medical Devices Regulation (EU 2017/745), better known as the Medical Devices Regulation (“MDR“), became applicable. The MDR builds on the old rules on medical devices, but at the same time is much more than the result of polishing up those old rules. The MDR brings change. Especially for developers of
MDR
software as a medical device in light of the new MDR: 12 points of consideration for developers (part 2 of 3)
On May 26, 2021, the Medical Device Regulation (EU 2017/745), better known as the Medical Devices Regulation (“MDR“), became applicable. The MDR builds on the old rules on medical devices, but at the same time is much more than the result of polishing up those old rules. The MDR brings change. Especially for developers of medical software
software as a medical device in light of the new MDR: 12 points of consideration for developers (part 1 of 3).
On May 26, 2021, the time had finally come. More than four years after its adoption, the Medical Devices Regulation (EU 2017/745) (“MDR“) became applicable. The fact that it took so long for the MDR to become applicable was in part due to the corona crisis. As a result, it was decided to delay the