Medical Device News, July 2024 Regulatory Update

Medical Device made Easy Podcast · Jul 5, 2024

Medboard

EU

Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422

Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/

MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf

MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES…