Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device”
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Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
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Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
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Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
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Guidance on Regulatory Practices for Combination Products
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