Medical Device News November 2025 Regulatory Update

Medical Device made Easy Podcast · Nov 12, 2025

MedBoard

EU

Joint clinical assessment procedure – EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086

Team-NB position paper on Companion diagnostics – Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf

MDR and IVDR put at risk transplantation – Donor Screening and SoHo preparation…