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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.
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.
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Explore in-depth on Rule 21, its intent and focus on the borderline nature with medicinal products.
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Explore the key aspects that manufacturers need to consider when developing a regulatory strategy.
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Conformity Assessment process.
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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.
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Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI
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