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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on …

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
      The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting ready Manufacturer IVD Manufacturers MD Manufacturers …

    Medicines and Medical Devices | Fact Sheets on the …

      https://www.europarl.europa.eu/factsheets/en/sheet/50/medicines-and-medical-devices
      Regulation (EU) 2017/745 and Regulation (EU) 2017/746 set the rules on placing medical and in vitro diagnostic devices on the market and on related clinical investigations. These …



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