News International Newsletter

Outcome Statement of IMDRF 25th session now available

Posted on 04.04.2024

The Outcome Statement of the 25th session of the International Medical Device Regulators Forum (IMDRF) that took place on 11-15 March 2024 in Washington DC has been recently published.

The document provides a high-level summary of the event and the decisions taken by the IMDRF Management Committee (MC), such as the accepted applications for IMDRF Affiliate membership.

The event, hosted by the US FDA and attended by regulators, industry and other stakeholders from over 60 countries, consisted of the Joint IMDRF/ Industry Workshop on Reliance, IMDRF Open Stakeholder Forum, IMDRF Management Committee Open Session, and IMDRF MC Closed Session.

The key topics discussed during the event include the importance of regulatory reliance in streamlining access to medical technologies, the acceptance of digital labels and electronic Instructions For Use (IFUs), and how training on IMDRF documents is going to be critical for broader education and implementation of IMDRF guidance and to facilitate greater regulatory convergence.

The slides presented at this March event are available here.

Established in October 2011, the IMDRF is a voluntary group of global medical device regulators who have come together to accelerate international medical device regulatory harmonisation and convergence.

For more information, please contact Dario Belluomini, Manager International Affairs.