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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    The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 Regulations The EU revised the laws governing medical devices and in vitro diagnostics to align with …

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 …

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 …

Medical Devices - New regulations - Public Health

    https://health.ec.europa.eu/medical-devices-new-regulations_en
    An official website of the European Union Public Health Home Medical Devices - New regulations Medical Devices - New regulations Overview The EU has …

Medical Devices - EUDAMED - Public Health

    https://health.ec.europa.eu/medical-devices-eudamed_en
    EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors …

New Regulations - Public Health

    https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
    The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure …

Public Health: medical devices - ec.europa.eu

    https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23/smo
    Public health: more time to certify medical devices to mitigate risks of shortages. Highlights, press releases and speeches ...

Getting ready for the new regulations - Public Health

    https://health.ec.europa.eu/medical-devices-new-regulations/getting-ready-new-regulations_en
    The new regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market …

The European Union Medical Device Regulation – …

    https://eumdr.com/
    Publication of MDCG 2021-24 Guidance on classification of medical devices. The EUDAMED UDI/Devices and NBs & Certificates modules are now open for economic …

MDR transition delay approved by EU Parliament and Council

    https://www.medicaldesignandoutsourcing.com/mdr-transition-delay-approved-eu-parliament-council/
    2 days ago · “I welcome today’s [European Parliament] vote to extend the transition period to new rules under the Medical Devices Regulation,” Commissioner for Health and Food …



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