Medical Device News: December 2021 Regulatory Update

Medical Device made Easy Podcast · Dec 7, 2021

EUDAMED

Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078

EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en

EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/

UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf

Infographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdf

Categorization of devices…