Are You Compliant with EU Medical Device Regulations?
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Are You Compliant with EU Medical Device Regulations?

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Questions and Answers

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?

  • 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?

  • 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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