EU - MDCG updates at year's end
In December the MDCG published new and updated guidance documents. MDCG 2025-9 on procedures for "breakthrough devices" and MDCG 2025-10 on post-market surveillance (PMS) have been added. MDCG 2025-7 on the master UDI-DI has been updated and is now available in revision 1. In addition the EU updated the "PMSV reporting forms" page, updating the helptext to the reporting form but not the form itself according to the changelog.