Skip to main content
QMSQMS
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

MDCG 2020-13 (CEAR) sections

Section-by-section markdown transcription of the MDCG 2020-13 Clinical Evaluation Assessment Report template (July 2020). Sections A–K.

📄️ 00 Front matter, introduction, scope, approach

Source MDCG 2020-13, Clinical evaluation assessment report template, July 2020)

📄️ Section A — Administrative particulars

Source MDCG 2020-13, Clinical evaluation assessment report template, July 2020)

📄️ Section B — Reviewers involved in the notified body assessment

Source MDCG 2020-13)

📄️ Section C (part 1) — Device description and classification

Source MDCG 2020-13)

📄️ Section C (part 2) — CEP, information materials, common specifications, equivalence, state of the art

Source MDCG 2020-13)

📄️ Section D — Clinical literature review

Source MDCG 2020-13)

📄️ Section E — Clinical investigations and related documentation

Source MDCG 2020-13)

📄️ Section F — PMS, PMCF and the plan for updates

Source MDCG 2020-13)

📄️ Section G — IFU, SSCP, labelling and other information supplied with the device

Source MDCG 2020-13)

📄️ Section I — Clinical evaluation consultation procedure (Article 54)

Source MDCG 2020-13)

📄️ Section J — Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10))

Source MDCG 2020-13)

📄️ Section K — The voluntary clinical consultation on the clinical development strategy (Article 61(2))

Source MDCG 2020-13)

📄️ Overall Conclusions

Source MDCG 2020-13)

Previous
Overview
Next
00 Front matter, introduction, scope, approach
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)