Thursday 26th of May 2022 is a significant day for those operating with in vitro diagnostic (IVD) medical devices in the European Union (EU). This is the date of application of the new EU Regulation 2017/746 on in vitro diagnostic medical devices (IVD Regulation, IVDR), from which the Regulation will be fully applicable, taking into […]
Category: Quality and regulation
Software in the medical device field – definition and risk classification according to the MDR
The image that pops into mind when hearing the term “medical device” often has something to do with physical devices or machines, such as x-ray machines or pacemakers. In addition to these, however, software is an increasingly important part of the medical device spectrum, both as stand-alone devices and as part of other devices. As […]
