The Netherlands

The European Regulation for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) will fully apply in 2020 and 2022, respectively. This new regulation will have consequences for the marketing authorization of medical devices.

The ministry of Health, Welfare and Sport (VWS) together with the Inspection and the Dutch National Institute for Public Health and the Environment (RIVM) developed a guide to help all parties prepare for 2020 and 2022. This guide includes the most important changes that come together with these new regulations and can be consulted here.

Share This