Medical Device News January 2026 Regulatory Update

• Medboard: https://www.medboard.com/
• Europe
  • EMD Mag Issue 3 – For QA RA people: https://easymedicaldevice.com/emd-mag/
  • EU to simplify MDR and IVDR – Proposal ongoing: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf  –  https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf  –  https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdf
  • Team NB Position Paper on Annex VII – Not agreeing all EU Proposal: https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdf
  • MDCG 2025-9 Learn Breakthrough Devices BtX – Guidance for innovative products: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
    • Infographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
  • MDCG 2025-10 on PMS – Learn how to do it with this guidance: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf
  • Notified Body Malta Conformity Assessment – 52nd Notified Body for MDR: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=SIMS_INPUT_282916&filter=notificationStatusId:1 

• Services
  • EasyIFU – Manage your eIFU and Labels: https://easyifu.com

• Switzerland
  • Swissdamed registration deadline – July 1st 2026: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html – https://swissdamed-webinar.ch/#E402A0
• UK
  • MHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees

• RoW
  • FDA: How to use Real World Evidence – Guidance Document offered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices
  • Australia: Preparing for UDI and AusUDID – Checklist for preparation available: https://www.tga.gov.au/sites/default/files/2025-12/preparing-for-udi-in-australia-checklist_0.pdf

• Podcast
  • Podcast Nostalgia – What was discussed lastly:
    • Episode 367 – From Engineer to Clinical Evaluation Expert – Florian Tolkmitt: https://podcast.easymedicaldevice.com/367-2/
    • Episode 368 – Simplifying EU MDR IVDR with Adam Isaacs Rae: https://podcast.easymedicaldevice.com/368-2/
    • Episode 369 – Last Podcast of the Year: https://podcast.easymedicaldevice.com/369-2/
    • Episode 370 – Verification & Validation with Aaron Joseph: https://podcast.easymedicaldevice.com/370-2/

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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