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 Device 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  

The EU Competent Authorities for Medical Devices (CAMD) is a group of EU national competent authorities established to promote collaborative working, communication, and surveillance of medical devices across Europe. CAMD works closely with the European Commission to improve strategic planning and participates in Joint Action projects. 

The HPRA is participating in Joint Actions which focus on reinforcing medical device market surveillance, harmonising regulatory approaches across the EU and Regulatory and Scientific Advice for small and medium sized enterprises. 

Heads of Medicines Agency Core Group for Medical Devices 

The Heads of Medicines Agencies (HMA) Core Group for Medical Devices is a working group within the HMA network composed of the heads of joint medicines and medical devices authorities, like the HPRA. HPRA Chief Executive participates in this group which focuses on improving the development of the regulatory system in the short and long term to ensure consistency, predictability, sustainability, and confidence. 

To learn more, visit the HMA website. 

International Medical Device Regulatory Forum  

The International Medical Device Regulatory Forum (IMDRF) is a group of medical device regulators from around the world that work together to accelerate global regulatory harmonisation and convergence.   

Through IMDRF, the HPRA contributes to a number of priority areas such as supporting and assisting with the development of guidance that establishes good regulatory review practices for regulatory authorities and/or their conformity assessment bodies, the development and promotion of IMDRF adverse event terminology and the development of safe and effective artificial intelligence/machine learning-enabled (AI/ML) medical devices. HPRA representatives also participate in the Forum’s working groups.  The HPRA is part of the EU delegation to the management committee of IMDRF. 

To learn more, visit the IMDRF website.