MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update

Medical Device made Easy Podcast · Sep 6, 2023

EU

MDR and IVDR communication Survey: https://ec.europa.eu/eusurvey/runner/MDR_and_IVDR_Communication_Survey

EU MDR transition

Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf

Flowchart to a decision on the extended MDR transitional period: https://health.ec.europa.eu/document/download/2d29bd99-8523-4c13-bbf5-cc36fcecea93_en?filename=md_devices-art120_flowchart.pdf

Team-NB: New MDR Transition Timeline and Notified Body Capacity…