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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 active …

New Regulations - Public Health

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

    Harmonised standards - Public Health

      https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
      The publications in the OJEU of references of harmonised standards under the medical devices regulations are available: For Regulation (EU) 2017/745 Search for …

    Medical devices - Internal Market, Industry, Entrepreneurship and …

      https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en
      Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the …

    Medical Device Regulation comes into application

      https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
      The MDR replaces the existing Directives for medical devices ( 93/42/EEC and 90/385/EEC ). The Regulation on in vitro diagnostic medical devices, which also …

    EUR-Lex - 32022R0112 - EN - EUR-Lex - Europa

      https://eur-lex.europa.eu/eli/reg/2022/112/oj/eng
      of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions …

    EUR-Lex - 32022D0006 - EN - EUR-Lex - Europa

      https://eur-lex.europa.eu/eli/dec_impl/2022/6/oj
      Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of …

    2022 Device Approvals | FDA - U.S. Food and Drug …

      https://www.fda.gov/medical-devices/recently-approved-devices/2022-device-approvals
      2022 Device Approvals | FDA 2022 Device Approvals The products listed in this section include some of the newest medical technology from the year 2022. The products in each …

    New UK MHRA Medical Devices Regulations Published - NAMSA

      https://namsa.com/uk-mhra-medical-device-regulations-published/
      New UK MHRA Medical Devices Regulations Published | NAMSA. On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority …

    Medical Device Directive vs Medical Device Regulation

      https://studycorgi.com/medical-device-directive-vs-medical-device-regulation/
      Introduction. The European Commission (EU) has decided that the current European Device Directive, or MDD, on medical devices is not strict enough. It has …



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