Design control process
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
1. Is the product "software" according to the definition?
This is the definition of software
Not covered by the MDCG Guidance
2. Is the software an “MDR Annex XVI device”, an accessory for a medical device according to Art. 2(2) of the MDR or IVDR or “software driving or influencing the use of a (hardware) medical device”?
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3. Is the software performing an action on data different from storage, archival, communication or simple search?
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4. Is the action for the benefit of individual patients?
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5. Is the software a Medical Device Software (MDSW) according to the definition of this guidance?<br />
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