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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 …

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. …

Medical Devices - New regulations - Public Health

    https://health.ec.europa.eu/medical-devices-new-regulations_en
    Setting the scene for EU reference labs for high-risk diagnostics 26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is …

New Regulations - Public Health

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

    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      The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 …

    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 - Latest updates - Public Health

      https://health.ec.europa.eu/medical-devices-sector/latest-updates_en
      MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the …

    Regulation (EU) 2017/745 - Wikipedia

      https://en.wikipedia.org/wiki/Regulation_(EU)_2017/745
      Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC …

    The Essential List of Regulatory Authorities …

      https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu
      To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website (s) for each country’s ministry of health …

    EU Medical Device Regulations | CMS MedTech

      https://cmsmedtech.com/eu-medical-device-regulations/
      The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that …



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