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/