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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health version 2.1 (Legacy MDD)
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 0: Background & Action Plan
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
        • MDCG 2020-13 & CER Template (reference)
          • MDCG 2020-13 (CEAR) sections
            • 00 Front matter, introduction, scope, approach
            • Section A — Administrative particulars
            • Section B — Reviewers involved in the notified body assessment
            • Section C (part 1) — Device description and classification
            • Section C (part 2) — CEP, information materials, common specifications, equivalence, state of the art
            • Section D — Clinical literature review
            • Section E — Clinical investigations and related documentation
            • Section F — PMS, PMCF and the plan for updates
            • Section G — IFU, SSCP, labelling and other information supplied with the device
            • Section I — Clinical evaluation consultation procedure (Article 54)
            • Section J — Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10))
            • Section K — The voluntary clinical consultation on the clinical development strategy (Article 61(2))
            • Overall Conclusions
          • CER Template sections
        • Adequacy review
        • Coverage matrix
        • task-3b2-3b3-legacy-rwe-study
        • task-3b4-mrmc-dark-phototypes
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • MDCG 2020-13 & CER Template (reference)
  • MDCG 2020-13 (CEAR) sections
  • Overall Conclusions

Overall Conclusions

Source: MDCG-2020-01.pdf page 25 (document: MDCG 2020-13)

Overall Conclusions​

Benefit-risk conclusions:

Summarise the clinical benefits. Describe them briefly in relation to the meaningful and measurable patient relevant clinical outcomes, including outcome(s) related to diagnosis. Describe their positive impact on patient management or public health.

Summarise the risks with clinical relevance (e.g uncertainties or limitations of clinical data, undesirable side-effects, potential for misuse, etc) and provide a short description (e.g. incidence, severity, duration, vulnerable patient subgroups, dose-response relationship where relevant, etc).

Discuss the impact of risks (as described above) in relation to the clinical benefits taking into account the factors described and in particular the uncertainties in relation to available clinical data.

Have all the risks that could have a significant impact on the benefit-risk analysis' been identified in the clinical evaluation?

Is there alignment between the risk management and clinical evaluation?

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Section K — The voluntary clinical consultation on the clinical development strategy (Article 61(2))
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CER Template sections
  • Overall Conclusions
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