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Questions and Answers
Which directives require a clinical evaluation for medical devices?
Which directives require a clinical evaluation for medical devices?
- Directive 93/42/EEC and Directive 2007/47/EC
- Directive 2007/47/EC and Directive 90/385/EEC
- Directive 90/385/EEC and Directive 2007/47/EC
- Directive 93/42/EEC and Directive 90/385/EEC (correct)
What is the legal status of the guidance document mentioned in the text?
What is the legal status of the guidance document mentioned in the text?
- It is not legally binding (correct)
- It has the same legal status as the Directives
- It is only applicable to in vitro diagnostic devices
- It supersedes the Directives mentioned in the text
What is the purpose of the guidance document mentioned in the text?
What is the purpose of the guidance document mentioned in the text?
- To regulate in vitro diagnostic devices
- To impose device-specific requirements
- To replace the Directives mentioned in the text
- To promote a common approach to clinical evaluation for medical devices (correct)
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