Strengthening international collaboration to regulate medical devices
The HPRA participates in European and international networks that support effective medical device regulation through shared expertise and resources.
Medical Device Coordination Group
The Medical Devices Coordination Group (MDCG) is an EU expert group established under the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. It advises and supports the European Commission and EU Member States in implementing these Regulations.
The MDCG's work is carried out through 13 subgroups, each providing expertise and drafting guidance on key areas such as Notified Body oversight, standardisation, market surveillance, new technologies and clinical investigations.
Members of these subgroups are appointed by Member States and HPRA experts represent Ireland. The subgroups meet regularly with the European Commission, which chairs the MDCG.
To learn about the MDCG and its subgroups, visit the European Commission website.
Competent Authorities for Medical Devices
EU CAMD was established to strengthen collaboration, communication and medical device surveillance across Europe. It supports the implementation and enforcement of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations.
To learn more, visit the CAMD website.
International Medical Device Regulatory Forum
The International Medical Device Regulatory Forum (IMDRF) is a voluntary group of medical device regulators from around the world that works to accelerate global regulatory harmonisation and convergence.
Through IMDRF, the HPRA contributes to developing common regulatory approaches and guidance on key and emerging issues, such as harmonising adverse event reporting to improve signal detection and supporting the development of safe AI‑enabled medical devices. HPRA representatives participate in the Forum’s working groups.
To learn more, visit the IMDRF website.