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New Regulations - Public Health

    https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

    Medical Devices - New regulations - Public Health

      https://health.ec.europa.eu/medical-devices-new-regulations_en
      Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746. News …

    Medical devices | European Medicines Agency

      https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
      The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

    Medical Device Regulation comes into application

      https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
      Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.. The Medical Device Regulation (MDR), which …

    How Europe’s New IVD Regulations Will Impact Labs

      https://www.aacc.org/cln/articles/2020/july/how-europes-new-ivd-regulations-will-impact-labs
      The European Union Medical Device Regulation was published on the same date as the IVDR with a planned 3-year transition through May 26, 2020, and it has been delayed by …

    The European Union Medical Device Regulation – …

      https://eumdr.com/
      A second c orrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of the …

    MDR transition delay approved by EU Parliament and Council

      https://www.medicaldesignandoutsourcing.com/mdr-transition-delay-approved-eu-parliament-council/
      2 days ago · The European Parliament and Council today voted to approve a Medical Device Regulation (MDR) transition delay in an effort to avoid shortages. The move …

    New EU regulations on medical devices: …

      https://www.prescouter.com/2020/01/new-eu-regulations-on-medical-devices-what-changes-from-may-26-2020/
      What is the impact of the new regulations on the EU medical devices industry? The European market for medical technology is estimated at €115 billion (based on …

    New European MDCG Guidance on Medical Device Vigilance …

      https://www.emergobyul.com/news/new-european-mdcg-guidance-medical-device-vigilance-requirements
      The long-awaited Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website. MDCG 2023-3, …

    Breaking News: EU Votes to Amend Medical Device …

      https://www.linkedin.com/pulse/breaking-news-eu-votes-amend-medical-device-regulation-
      Medical device manufacturers have new deadlines to meet in order to comply with the amended regulation. To review the full document please visit this …



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