Key regulatory considerations for health institutions in Ireland using medical devices and IVDs
This page is for Irish health institutions.
It sets out some of the key considerations when sourcing and using medical devices and IVDs in health institutions in Ireland.
This page contains both written content and video content. We encourage Irish health institutions to consider both our written and video content.
HPRA information day for Irish health institutions using medical devices and IVDs
In May 2025, we hosted an information day for Irish health institutions using medical devices and IVDs. This information covered key topics of relevance to Irish health institutions including an overview of how devices are regulated, alternative routes for using devices in hospitals and how to conduct safety reporting. We have made the recordings of this information day available below.
We encourage Irish health institutions to review and consider this content.
Overview of regulatory requirements for medical devices and IVDs
Dr. Niall MacAleenan outlines the application of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), highlighting key areas relevant to Irish health institutions.
Overview of regulatory requirements for medical devices and IVDs: Part 1
Nicola Hickie discusses regulatory considerations for Irish health institutions, covering system requirements, CE marking, post-2021 regulatory changes, and the roles of the HPRA and health institutions in implementing the Regulations.
Overview of regulatory requirements for medical devices and IVDs: Part 2 - YouTube
Alternative routes for health services using medical devices and IVDs – unmet need and clinical research
In this presentation, Dr Donal O’Connor discusses alternative routes for using medical devices and IVDs and conducting clinical research within Irish healthcare settings. With reference to examples and sample cases, key topics include compassionate use authorisations, derogations, clinical investigations and performance studies.
Alternative
routes for hospital use of medical devices – unmet need and clinical research
Safety reporting and field safety corrective actions for medical devices and IVDs – information for Irish health services
In this presentation, Patrick Murphy provides an overview of safety reporting and field safety corrective actions. This presentation covers key questions such as what to report and how and when to report incidents. It also covers aspects relating to traceability and HPRA communications relating to safety issues.