Medical Device NewsMAY 2024 Regulatory Update

Medical Device made Easy Podcast · May 2, 2024

EU

Notified Bodies

TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true

AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1

MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD…