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    EU MDR Rule 21 - Diverse group of male and female staff members working in a lab
    • Webinar
      Medical Devices

    EU MDR Rule 21

    The EU-MDR Rule 21 applies to all substance-based medical devices and is a new rule for medical devices.

    Watch the Webinar View the Presentation

    Rule 21 principal mode of action is by physical or simple chemical means

    Gain an appreciation of the background to the inclusion of this new rule in the MDR and of expectations for the Conformity Assessment process.

    • Explore in-depth on Rule 21, its intent and focus on the borderline nature with medicinal products.

    • Explore the key aspects that manufacturers need to consider when developing a regulatory strategy.

    • Conformity Assessment process.

    • Common Issues and misinterpretation of the Rule 21 Devices.

    EU MDR Rule 21

    Watch the webinar for an in-depth explore on Rule 21 and its intent and focus on the borderline nature with medicinal products.

    Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI
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