Medical Device News JUNE 2025 Regulatory Update

Europe

• Notified Body survey report – 31 October 2024 – What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
• The MIR form has been updated – Version 7.3.1 – Don’t use previous versions: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en

UK

• UK MIR and FSCA – Change is in the AIR: https://www.gov.uk/government/publications/more-implementation/gb-mir-and-fsca-schema-implementation-guide
• UK MDR 2002 is dying – Long life to UK MDR 2025: https://www.legislation.gov.uk/ukdsi/2025/9780348269529
• : Real-World Data or Clinical Trial or Both?- This is the question: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions

Training

• EU MDR Green Belt June 2025 – June 23rd, June 27th: https://school.easymedicaldevice.com/course/gb34/
• eTraining on Vigilance and Audit preparation – Self-paced: https://school.easymedicaldevice.com/emd-course

ROW

USA

• Q-Sub update  – New electronic template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-q-submissions

Brazil

• SIUD or UDI in Brazil – Manual of Use in Portuguese: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/manual_siud_v01.pdf

Saudi Arabia

• Series of Webinar – June is a Busy month in Saudi Arabia:
  • 16 June 2025 Companion Diagnostic Regulatory Requirements: https://www.sfda.gov.sa/en/workshop/3540492
  • 17 June 2025 Saudi Unique Device Identification (SAUDI-DI): https://www.sfda.gov.sa/en/workshop/3540493
  • 19 June 2025 Artificial Intelligence and Machine Learning: https://www.sfda.gov.sa/en/workshop/3540495
  • 23 June 2025 Digital Health Medical Devices regulatory approach: https://www.sfda.gov.sa/en/workshop/3540496
  • 24 June 2025 Medical Devices Risk Classification: https://www.sfda.gov.sa/en/workshop/3540497
• Saudi In-house Devices – Not like EU: https://www.sfda.gov.sa/sites/default/files/2025-05/MDS-G022En.pdf

Turkey

• In Turkey, Economic Operators are Liable – Even after discontinuation or temporary stop of supply: https://titck.gov.tr/duyuru/tibbi-cihazlarin-tedarikinin-kesintiye-ugramasi-veya-durdurulmasi-sona-ermesi-durumunda-i-ktisadi-i-sletmecilerin-yukumlulukleri-hakkinda-duyuru-21052025113350

PODCAST

• Podcast Nostalgia – What happened in May 2025
  • Episode 334 – What is the new UK Post-Market Surveillance Requirements? With Claire Dyson: https://podcast.easymedicaldevice.com/334-2/
  • Episode 335 – When is Regulatory Affairs needed during Design? With Aouda Ouzza: https://podcast.easymedicaldevice.com/335-2/
  • Episode 336 – is EHDS dangerous for Medical Device Manufacturers? With Cecile van der Heijden: https://podcast.easymedicaldevice.com/336-2/
  • Episode 337 – How Deepeye Medical overcame the AI Act? With Carmen Bellebna; https://podcast.easymedicaldevice.com/337-2/
  • Episode 338 – Trapped or Strategic? Changing Notified Bodies During MDR transition: https://podcast.easymedicaldevice.com/338-2/

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice