Medical Device News March 2025 Regulatory Update

Medical Device made Easy Podcast · Mar 13, 2025

Sponsor

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

Europe

Health Data Legislation – Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500327&qid=1741166600030

FAQ: https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf

eIFU proposal until March 21st- eIFU for professional user: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14470-Medical-devices-electronic-instructions-for-use_en

14th Notified Body Under IVDR – Centro Nacional de Certification de Productos…