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Harmonised standards - Public Health

    https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
    For Regulation (EU) 2017/746 on in vitro diagnostic medical devices: Commission Implementing Decision (EU) 2022/729 of 11 May 2022 Commission Implementing Decision (EU) 2022/15 of 6 January 2022; Commission Implementing …

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 …

New publication of Harmonised standards under the medical …

    https://health.ec.europa.eu/latest-updates/new-publication-harmonised-standards-under-medical-devices-regulations-2022-05-17_en
    New publication of Harmonised standards under the medical devices Regulations Visit page Details Publication date 17 May 2022 Author Directorate-General …

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 …

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    The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

ISO - ISO 13485 — Medical devices

    https://www.iso.org/iso-13485-medical-devices.html
    ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external …

Harmonized Standards List - Medical Device Regulation

    https://www.medical-device-regulation.eu/mdr-resource-harmonized-standards-lis/
    EN ISO 17664:2004 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) EN …

Ultimate List of ISO Standards for Medical Devices

    https://www.greenlight.guru/blog/iso-standards
    The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for …

EU Classification of Medical Devices with examples

    https://omcmedical.com/eu-classification-of-medical-devices-with-examples/
    Medical devices range from low-risk products such as thermometers to high-risk devices such as pacemakers. In the European Union, the medical devices are …



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