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.
Notified bodies
What is a notified body, how to apply to become one, and what our role is for NBs.
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HPRA inspections
An overview of the inspection process including who, what and how we inspect.
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Certificates of free sale
Find out how to apply for certificates of free sale including links to application forms.
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Compassionate use applications
Learn more about compassionate use applications for medical devices.
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