Annex I — Methodological principle for generation of clinical evidence

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

Annex I — Methodological principle for generation of CLINICAL EVIDENCE

Figure (page 17) — Methodological principle for generation of CLINICAL EVIDENCE.

The diagram is a four-stage flowchart (with a cross-cutting fifth stage for continuous clinical/performance evaluation) that shows how the three evaluation components are consolidated into a single clinical evidence body. Stages are depicted as horizontal bands, each labelled on the left-hand margin:

• STAGE 1 — Valid Clinical Association / Scientific Validity
• STAGE 2 — Technical/Analytical Performance
• STAGE 3 — Clinical Performance
• STAGE 4 — Compilation of Clinical Evidence
• STAGE 5 — Continuous clinical / performance evaluation (shown as a vertical band running alongside Stages 2 and 3)

The flow proceeds through six numbered steps:

• From the MDSW input, Data supporting clinical association (SotA) [4.2] feeds into STEP 1 — Appraisal and analysis of data supporting clinical association.
• Decision node: "Is the Valid Clinical Association / Scientific Validity established?"
  • NO → STEP 2 — Gap analysis of Clinical Association / Scientific Validity information → Collect more information in support of Valid Clinical Association / Scientific Validity (loops back to the "Data supporting clinical association (SotA) [4.2]" input).
  • YES → proceeds to Stage 2.
• STEP 3 — Generation, appraisal and analysis of Technical / Analytical performance data [4.3] (Stage 2).
• STEP 4 — Identification and/or generation of sufficient clinical performance data (Stage 3).
• Decision node: "Clinical Investigation / Clinical performance study according to Art. 61.4 MDR / 56.4 IVDR? [4.4.1]"
  • YES → STEP 5 — Clinical Investigation or Clinical performance study.
  • NO → bypasses Step 5 and joins the next decision node directly.
• Decision node: "Are the Clinical Performance data in conjunction with the Technical/Analytical performance, Valid Clinical Association / Scientific Validity and clinical usability data sufficient to demonstrate conformity with the relevant GSPRs?"
  • NO → returns to STEP 4 (and an annotation indicates that "Clinical data can potentially be reanalysed to serve as additional input to Valid Clinical Association / Scientific Validity [4.2]").
  • YES → proceeds to Stage 4.
• STEP 6 — Prepare Clinical Evaluation Report / Performance Evaluation Report [4.5] → Add to Technical Documentation (Stage 4).