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

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