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New Regulations - Public Health

    https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
    1. Commission Implementing Regulation (EU) 2022/2347of 1 December 2022 l…2. Commission Implementing Regulation (EU) 2022/2346of 1 December 2022 l…3. Commissio… See more

Clinical Trials Regulation | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
    European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers …

Harmonised standards - Public Health

    https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
    Commission Implementing Decision (EU) 2022/729 of 11 May 2022 Commission Implementing Decision (EU) 2022/15 of 6 January 2022; Commission …

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 …

Medical Devices - New regulations - Public Health

    https://health.ec.europa.eu/medical-devices-new-regulations_en
    26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU News announcement 26 May 2021 Notice to …



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