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          • Source Document Verification Audit (2026-04-06)
          • MDCG-2020-1
            • MDCG 2020-1 sections (markdown)
              • 00 Front matter and table of contents
              • 1-2. Purpose and Scope
              • 3. Background, abbreviations, and definitions
              • 4. General principles — Introduction and Pillar 1 (Valid Clinical Association)
              • 4.3 Technical Performance / Analytical Performance (Pillar 2)
              • 4.4 Clinical Performance (Pillar 3)
              • 4.5-4.6 Final analysis, conclusion, and continuous update
              • Annex I — Methodological principle for generation of clinical evidence
              • Annex II — Examples of clinical evaluation / performance evaluation strategies
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  • Round 1
  • Item 0: Background & Action Plan
  • MDCG-2020-1
  • MDCG 2020-1 sections (markdown)

MDCG 2020-1 sections (markdown)

Section-by-section markdown transcription of MDCG 2020-1 (Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software, March 2020). This is the document that sets the three-pillar framework (VCA, Technical Performance, Clinical Performance) the Clinical Evaluation Plan (R-TF-015-001) and Clinical Evaluation Report (R-TF-015-003) align against.

📄️ 00 Front matter and table of contents

Source: MDCG 2020-1 (Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software, March 2020), pages 1-2

📄️ 1-2. Purpose and Scope

Source: MDCG 2020-1 (March 2020), pages 3-4

📄️ 3. Background, abbreviations, and definitions

Source: MDCG 2020-1 (March 2020), pages 4-8

📄️ 4. General principles — Introduction and Pillar 1 (Valid Clinical Association)

Source: MDCG 2020-1 (March 2020), pages 9-11, covering Section 4 opener + 4.1 Introduction + 4.2 Determination of the valid clinical association / scientific validity

📄️ 4.3 Technical Performance / Analytical Performance (Pillar 2)

Source: MDCG 2020-1 (March 2020), pages 12-13

📄️ 4.4 Clinical Performance (Pillar 3)

Source: MDCG 2020-1 (March 2020), pages 13-15

📄️ 4.5-4.6 Final analysis, conclusion, and continuous update

Source: MDCG 2020-1 (March 2020), pages 15-16

📄️ Annex I — Methodological principle for generation of clinical evidence

Source: MDCG 2020-1 (March 2020), page 17

📄️ Annex II — Examples of clinical evaluation / performance evaluation strategies

Source: MDCG 2020-1 (March 2020), pages 18-21

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00 Front matter and table of contents
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