Medical Device News – July 2023 Regulatory Update

Medical Device made Easy Podcast · Jul 4, 2023

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

EU

Annex XVI transition https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194

Cybersecurity and privacy in AI https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosis

ANSM wants barcode on Field Safety Notice https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes

AEMPS clinical trials involving drugs and medical devices…