Highlights from the 24th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) in Berlin, Germany

In September 2023, Berlin hosted the 24th IMDRF Management Committee meeting, chaired by the EU and attended by over 550 global participants over five days, revealing significant developments in medical device regulation.

1. IMDRF/DITTA-GMTA Joint Workshop (25 September 2023):
   • Explored tailored medical devices (MDs) for specific patient demographics (e.g., orphan, humanitarian, paediatric, custom MDs).
   • Examined innovative MDs, their global regulatory pathways, and potential international collaboration.
   • Introduced regulatory toolboxes for innovation, including regulatory sandboxes and predetermined change control plans (PCCPs).
2. IMDRF Stakeholder Forum (26 September 2023):
   • Shared regulatory updates from IMDRF MC Members and Official Observers.
   • Highlighted ongoing projects, including Medical Device Vigilance Program (Australia), Adverse Event Terminology (USA/EU), Medical Device Cybersecurity Guide (USA/Canada), and more.
   • Introduced ‘flash panel’ discussions on topics like Unique Device Identification (UDI) and Digital Therapeutics.
3. IMDRF Management Committee Open Session (27th September):
   • Offered updates on Regional Harmonization Initiatives (RHIs) and Invited Observers.
   • Notable mentions included the African Medical Devices Forum (AMDF), Central Drugs Standard Control Organization (CDSCO) (India), and Egyptian Drugs Authority (EDA).
4. IMDRF Management Committee Closed Session (28 – 29 September 2023):
   • Deliberated on membership applications and IMDRF governance documentation.
   • Highlighted the release of the IMDRF training pilot on adverse event terminology.

For those interesting in delving deeper into the specifics, all presentation materials from the IMDRF/DITTA-GMTA workshop and the IMDRF Stakeholder Forum can be accessed online.

Overall, the 24th IMDRF Management Committee Meeting served as a testament to the ongoing collaborative efforts to streamline and enhance medical device regulations on a global scale, ensuring safety, innovation, and accessibility.