Medical Device News January 2026 Regulatory Update cover art

Medical Device News January 2026 Regulatory Update

Medical Device News January 2026 Regulatory Update

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 Medboard: https://www.medboard.com/EuropeEMD 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).pdfTeam 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.pdfMDCG 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.pdfInfographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuIMDCG 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.pdfNotified 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 ServicesEasyIFU - Manage your eIFU and Labels: https://easyifu.com SwitzerlandSwissdamed 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/#E402A0UKMHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees RoWFDA: 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-devicesAustralia: 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 PodcastPodcast 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/
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