Medical Device News, Septembre 2024 Regulatory Update

Medical Device made Easy Podcast · Sep 10, 2024

EU

e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN

MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf

Implementing Act IVDR Common specifiaction – Consultation until Sept 16th: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14383-In-vitro-diagnostic-medical-devices-common-specifications_en

Cyber Security in Health and medicine – Results from Cyber…