Quiz: Assembling the Technical File for an AI Medical Device

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Question 1 of 5

1. Question

The technical file for an AI medical device must be accurate, complete, and clearly structured to allow regulators to assess whether the device meets applicable requirements.

The technical file must be stored in a cloud-based system to ensure accessibility.
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The technical file must be accurate, complete, and clearly structured to allow regulators to assess whether the device meets applicable requirements.
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The technical file must include clinical trial data from international markets only.
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The technical file must be reviewed annually but does not require updates after significant changes.
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Question 2 of 5

2. Question

The EU AI Act’s Article 5 prohibits certain AI practices such as real-time biometric identification which must not be used in medical devices.

The EU AI Act’s Article 5 prohibits the use of AI in clinical decision-making processes.
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The EU AI Act’s Article 5 prohibits certain AI practices such as real-time biometric identification which must not be used in medical devices.
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The EU AI Act’s Article 5 allows social scoring in medical devices under specific conditions.
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The EU AI Act’s Article 5 applies only to software-based medical devices and not AI systems.
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Question 3 of 5

3. Question

The technical file must include records of AI governance such as data protection impact assessments and AI risk assessments.

The technical file must include clinical data from at least five clinical centres.
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The technical file must include records of AI governance such as data protection impact assessments and AI risk assessments.
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The technical file must contain clinical validation data from at least two clinical investigations.
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The technical file must include clinical utility assessments but not clinical data sources.
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Question 4 of 5

4. Question

ISO/IEC 42001:2023 provides a framework for AI management systems and must be reflected in the technical file.

ISO/IEC 42001:2023 is only applicable to software-based medical devices and not AI systems.
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ISO/IEC 42001:2023 provides a framework for AI management systems and must be reflected in the technical file.
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ISO/IEC 42001:2023 was first accredited by UKAS on 15 January 2026.
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ISO/IEC 42001:2023 is not required for AI medical devices under EU regulations.
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Question 5 of 5

5. Question

The technical file must be maintained as a living document and reviewed at least annually or whenever significant changes occur.

The technical file must be reviewed every five years regardless of any changes.
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The technical file must be maintained as a living document and reviewed at least annually or whenever significant changes occur.
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The technical file must be stored in a physical format to meet regulatory requirements.
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The technical file must not be updated after clinical validation is completed.
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Quiz: Assembling the Technical File for an AI Medical Device

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