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. 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). IMDRF Stakeholder Forum (26 September 2023): Shared regulatory updates from IMDRF MC Members and......

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