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/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

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