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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
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  • BSI Non-Conformities
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 1: CER Update Frequency
          • Question
          • Research and planning
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
    • BSI Non-Conformities
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 1: CER Update Frequency
  • Question

Question

Requirements and references​

  • Article 86
  • Article 61(11)

MDF reference​

CER updates

Question​

Requirements​

  • Article 86 states that the PSUR for Class IIa and IIb devices shall be updated at least every 2 years
  • Article 61 (11) states that the clinical evaluation shall be updated based on clinical data obtained from the implementation of the post market plans

Observations​

§18 of the CER does not seem to specify a regular cadence for the update frequency of the CER (e.g. every 2 years, etc)

Request​

Please provide a clear update frequency cadence for the clinical evaluation as aligned to requirements in Articles 61 (11) and Article 86.

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Clinical Review: Round 1
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Research and planning
  • Requirements and references
  • MDF reference
  • Question
  • Requirements
  • Observations
  • Request
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