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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 …

Medical Device Approval. European Regulatory Process.

    https://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/european-medical-device-regulatory-approval-process/
    The role of the European Commission in Medical Device Approval: This is the executive body within the European Union which has responsibility for proposing legislation. The Commission determines the requirements for …

Europe CE Marking Regulatory Process for Medical Devices

    https://www.emergobyul.com/resources/europe-ce-marking-regulatory-process-medical-devices
    Determine which EU Medical Device Directive applies to your device: …

Europe: Medical Device Market Approval | Credevo Articles

    https://credevo.com/articles/2020/08/05/europe-medical-device-market-approval/



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