Medical Device News January 2025 Regulatory Update

Medical Device made Easy Podcast · Feb 6, 2025

Medboard

EU

EU MDR and IVDR article 10a – Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a

EU IVDR transition periods – Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdf

EUDAMED

EMDN: UPDATE or not to UPDATE – MDCG 2024-2 Rev 1 and 2021-12 Rev 1 :

https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf

MDCG 2024-2…