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Fact sheet on European Medical Device Regulation

The MDR is a European Union regulation for the registration of safe medical devices. The regulations in this new law have consequences for healthcare providers, caregivers and ultimately for their clients. Vilans has been commissioned by the Dutch Ministry of Health, Welfare and Sport to publish a fact sheet and guide to support the implementation of the MDR.

The MDR (Medical Device Regulation) outlines a renewed framework for the quality of medical devices with the goal of ensuring that the devices are safe to use. In addition, it is important that patients/clients and healthcare professionals have easy access to adequate information about the devices thanks to the new regulation, so they can make informed decisions about the deployment and use of these devices.

Fact sheet and guide

The Fact Sheet prepared by Vilans is written in Dutch for care providers in the Netherlands. However you will find more detailed information about the MDR on the European Medicines Agency website.