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=986770If 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