Medical Device News DECEMBER 2025 Regulatory Update
Description
Medboard
Europe
48% disruption in the EU - I hope you are all healthy: https://health.ec.europa.eu/document/download/13b2c812-b144-4489-af1f-e76af5bc97fd_en?filename=md_availability_study_presentation_2024.pdf
Consultation: SCHEER asks you - Are Brain Stimulators for non-medical purpose dangerous: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-scientific-opinion-health-hazards-and-risks-associated-use_en
Q&A Medicines used with Medical Devices - Revision 6 with new questions: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
EUDAMED is Mandatory - From 28 May 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502371 - https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
UK
Better Call MHRA - But we don't consult: https://www.gov.uk/guidance/medical-devices-get-regulatory-advice-from-the-mhra
Standard
ISO 10993-1 mutation - Nothing is automatic anymore: https://www.youtube.com/watch?v=AkSZVNSz5a0
ISO 18969 draft - Comments until 28-01-2026: https://www.youtube.com/watch?v=zCR9HlHJ5l0
EasyIFU
Create your Labels with EasyIFU - UDI included: https://easyifu.com
Rest of the World
Argentina
Argentina: Simplified application - Class I/A or Class II/B: https://www.argentina.gob.ar/noticias/anmat-establece-un-regimen-simplificado-para-la-habilitacion-de-establecimientos
Canada
Canada: Modernization of the MDEL - Some changes: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-modernizing-mdel-framework-phase-ii.html
Canada: Medical Device License Application - Guidance on how to do it: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses.html
Brazil
Brazil: Digitalisation of Certificates - You can request that online now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-lanca-nova-ferramenta-para-emitir-certificados-de-dispositivos-medicos
Podcast
Podcast Nostalgia - Let's review previous podcasts
Episode 363 - The journey of a CRO with Helene Quie: https://podcast.easymedicaldevice.com/363-2/
Episode 364 - What is changing with the new ISO 10993-1 with Marina Daineko: https://podcast.easymedicaldevice.com/364-2/
Episode 365 - How to become a Lead Auditor with Rob Packard: https://podcast.easymedicaldevice.com/365-2/
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
United States
