Medical Devices: COVID-19 Updates

The HPRA provides information on this webpage related to COVID-19 and the regulation of medical devices. 

Continuity of supply of medical devices

The HPRA is working in partnership with the Department of Health and the HSE to minimise and proactively address any risks posed to the ongoing supply of medical devices to Irish health institutions and patients. This work programme involves liaising closely with industry stakeholders, including representative bodies, manufacturers and distributors, so that there is continued access to the devices used by healthcare professionals to diagnose and to treat patients with COVID-19. 

The HPRA provides information and updates on this section of the website related to COVID-19 and the regulation of medical devices. Please click on the titles listed below for more information.

This webpage includes information about in-vitro diagnostic medical devices (IVDs) used to detect COVID-19, including information about rapid antigen tests, limitations of tests, how to report safety issues and links to useful resources. 

The HPRA, together with other EU regulatory authorities, developed a notice to remind manufacturers of important points to consider before putting nasal sprays claiming virucidal and antimicrobial actions on the market as medical devices.

The HPRA published a Safety Notice highlighting that a number of thermometers placed on the Irish market do not meet regulatory requirements for medical devices and may not perform as intended. The Safety Notice outlines the precautions to take when buying a thermometer. 

This webpage contains information on the regulation of face masks and gloves, including links to information published by the European Commission and the Health and Safety Authority. 

This webpage outlines how healthcare professionals and members of the public can report a safety issue relating to a medical device.