The Health Products Regulatory Authority (HPRA) is the regulatory body responsible for monitoring the safety and performance of medical devices and in-vitro diagnostic medical devices (IVDs) in Ireland. Medical devices are products, equipment, or software intended by its manufacturer for a medical purpose, such as diagnosing, treating, or preventing disease, or managing illness, injury, or other health conditions. In-vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health.
Within the EU, medical devices are regulated under the Medical Device Regulation and in-vitro diagnostic medical devices are regulated under the In-vitro Diagnostic Medical Device Regulation.
Find more information: www.hpra.ie.