Medical Device News June 2024 Regulatory Update

Medical Device made Easy Podcast · Jun 6, 2024

EUROPE

EU MDR 26 May 2024 – Was there any apocalypse:

France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition

Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering

EU shortage managed – EUDAMED and IVD extension also discussed…