Medical Device News JULY 2025 Regulatory Update

Medical Device made Easy Podcast · Jul 3, 2025

Medboard: https://www.medboard.com/

EUROPE

new eIFU rules – Let’s save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj

https://health.ec.europa.eu/latest-updates/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en

EasyIFU.com

MDR + IVDR + AI Act = MDCG 2025-6 – Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf

MDCG 2025-5: IVDR Performance Study – Masterclass to understand Performance Study…