Medical Device News September 2025 Regulatory Update скачать в хорошем качестве

Medical Device News September 2025 Regulatory Update

Medboard   EUROPE Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/... Updated - Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/... There's a significant backlog: far more applications submitted than certificates issued, especially for IVDs. Time for certification: between 13 to 18 months on average Delay due to application missing critical information and refusal due to submission outside NB scope No transparency on capacity Germany new radiation protection regulation - Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/... If device emit radiation and need clinical investigation in germany: Include a radiation risk assessment in your clinical investigation dossier Coordinate with Radiation protection authorities Update investigator brochure and patient information Stricter Monitoring & Reporting Impact on Timelines So stricter documentation, more authorities involved and longer approval times   UK MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mh... - https://www.gov.uk/guidance/notify-mh...   Switzerland New in Swissdamed - Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/... 1 july-2026   Magazine Easy Medical Device Mag - Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/...   Podcast: Best 40 Medical Device Podcast - Thanks: https://www.millionpodcasts.com/Medic...   REST OF THE WORLD SaMD and/or Artificial Intelligence on the spotlight - All countries want their regulation on it: USA: PCCP - https://www.fda.gov/regulatory-inform... SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4... TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guid... SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/re... Medical Device or Wellness device - Choose your side: https://www.sfda.gov.sa/sites/default...