Common aspects of the device regulations
This webpage covers topics that apply both to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Visit the following topics if you would like more information.
For information on topics specific to the MDR, please see our MDR webpage. For information on topics specific to the IVDR, please see our IVDR webpage.
What is a notified body, how to apply to become one, and what our role is for NBs.
Learn moreAn overview of the inspection process including who, what and how we inspect.
Learn moreFind out how to apply for certificates of free sale including links to application forms.
Learn moreLearn more about compassionate use applications for medical devices.
Learn moreLearn more about interruptions or discontinuations of medical device or IVD supply.
Learn more