News Category: Regulatory news
The HPRA participated in a workshop in early July of EU Competent Authorities for medical devices with the aim to review the status of the EU regulatory framework for medical devices. Alongside EU Commission representatives, the priorities, challenges and solutions regarding implementation were identified and discussed.
Following the workshop the Competent Authorities for medical devices have endorsed a consensus statement on the status of the EU regulatory framework for medical devices. The statement outlines the importance of the MDR and IVDR in the protection of public health and outlines key areas to work towards which will form the basis for future work.
The consensus statement and further details can be found on the HMA Core Group website.