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Home » C1 M4 part4 single 2nd

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C1 M4 part4 single 2nd

28DGTL 14/07/2026

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Question 1 of 2

1. Question

Which two EU regulations will most likely apply to this system?

GDPR and MDR
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MDR and EU AI Act
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FDA and GDPR
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MDR and ISO 13485
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Question 2 of 2

2. Question

Which of the following are required under the EU AI Act for high-risk systems like this?
(Select all that apply)

Data governance and documentation
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Human oversight and intervention
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Algorithm transparency and explainability
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Annual CE certificate renewal
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Cybersecurity and resilience measures
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