14.06.2024
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Statistical requirements for applications for authorisation of a clinical trial with medical devices
The BfArM has summarised the requirements for statistics in clinical trials with medical devices in a guideline.
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18.06.2024
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SAE and DD reporting for clinical investigations
SAE and DD reporting for clinical investigations
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30.04.2024
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Request for classification and/or qualification decision
Request for classification and/or qualification decision
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02.04.2024
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Reporting channels according to MDR, IVDR and MPDG
Overview of the reporting channels for notifications, applications and reports according to MDR, IVDR and MPDG.
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03.04.2024
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Differentiation and classification
Medical devices are assigned to risk classes. With the exception of in-vitro diagnostics, medical devices are classified according to the classification rules in Annex VIII MDR.
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25.03.2024
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Database Information Medical Devices Notification
Database Information Medical Devices Notification
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25.03.2024
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Database Information Medical Devices Addresses
Database Information Medical Devices Addresses
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25.03.2024
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Database Information In Vitro Diagnostic Medical Devices Notifications
Database Information In Vitro Diagnostic Medical Devices Notifications
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