Medical Device News May 2026 Regulatory Update

Medical Device made Easy Podcast · May 13, 2026

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

Europe

EUDAMED: It’s Go Time -May 28th 2026 for New Products:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1860&qid=1720686388639

https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf

Brand new Notified Body Rules -Implementation regulation 2026/977

https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

https://www.medtecheurope.org/resource-library/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/

EU MDR IVDR…