Medical Device News June 2026 Regulatory Update

Medical Device made Easy Podcast · Jun 3, 2026

Sponsor Medboard

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

EUROPE

Europe Starts Regulating the Regulators – Implementing Regulation (EU) 2026/977: https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

EUDAMED is mandatory – Panic is raising: https://health.ec.europa.eu/medical-devices-eudamed/overview_en

Germany: https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/DMIDS-anleitung-anzeigepflichtige-mp-ivd.pdf?__blob=publicationFile

Belgium: https://www.famhp.be/en/news/eudamed_clarifications_regarding_obligations_from_28_may_2026

Portugal…