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Home > Medical Device made Easy Podcast > Medical Device News September 2025 Regulatory Update


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News September 2025 Regulatory Update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2025-09-04 23:44:40
	Description:		Medboard EUROPE Guidance on the implementation of the Master UDI-DI – MDCG 2024-14 – rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf Updated – Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf 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/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770 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/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout – https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device Switzerland New in Swissdamed – Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html 1 july-2026 Magazine Easy Medical Device Mag – Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1 Podcast: Best 40 Medical Device Podcast – Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/ 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-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139 TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/ Medical Device or Wellness device – Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf The post Medical Device News September 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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