Medical Device News -June 2023 regulatory update

Medical Device made Easy Podcast · Jun 8, 2023

Sponsor MedBoard: www.medboard.com

EUROPE

Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf

EU MDR and IVDR consolidated versions

EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320

EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320

Confirmation letter: EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en

MDCG 2020-3 Significant changes…