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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 framework for medical devices, introducing new responsibilities for EMA and national …

New Regulations - Public Health

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

    Medical Device Regulation comes into application

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

    Medical Devices - New regulations - Public Health

      https://health.ec.europa.eu/medical-devices-new-regulations_en
      Medical Devices - New regulations Overview The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting ready …

    The European Union Medical Device Regulation – …

      https://eumdr.com/
      The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices …

    Medical Devices - Sector - Public Health

      https://health.ec.europa.eu/medical-devices-sector_en
      The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New …

    Guidance - MDCG endorsed documents and other guidance

      https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
      This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) Search for available translations of the …

    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, …

    European Medical Device Regulation | Deloitte Netherlands

      https://www2.deloitte.com/nl/nl/pages/risk/articles/european-medical-device-regulation.html
      The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safe and effective performance of medical …

    Download MDR - Medical Device Regulation

      https://www.medical-device-regulation.eu/download-mdr/
      Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and …



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