Clinical Evidence and Regulation Guides
In-depth Clinical Evidence and Regulation guides for research, medtech and medical-AI teams. Methodical, sourced and defensible practice.
5 articles
Clinical Evidence and Regulation
Equivalence in the CER: How to Build the MDCG 2020-5 Evidence Table
Equivalence under MDR Annex XIV Part A(3) and MDCG 2020-5: demonstration in all three of technical, biological and clinical characteristics, the single-device rule, the data-access requirement, the Article 61(5) limit, and the structure of the comparison table a Notified Body accepts.
September 16, 2026 · 7 min read
Clinical Evidence and Regulation
Notified Body Findings on the CER Literature Search: 7 Recurring Errors
Why the literature section of an MDR clinical evaluation report comes back: the 7 points a Notified Body assessor checks under MEDDEV 2.7/1 Rev 4 Appendix A5 and MDCG 2020-13, and how to fix each one before submission.
September 16, 2026 · 7 min read
Clinical Evidence and Regulation
IVDR Clinical Performance Study: Sensitivity, Specificity and Sample Size
How to design the clinical performance leg of an IVDR Annex XIII performance evaluation: reference standard, separate sample-size calculations for sensitivity and specificity, confidence-interval-based acceptance criteria and reporting under MDCG 2022-2 and ISO 20916.
September 16, 2026 · 7 min read
Clinical Evidence and Regulation
Literature Appraisal in Clinical Evaluation: MEDDEV 2.7/1 Appendix A6
How every study included in a CER is scored: the MEDDEV 2.7/1 Rev 4 Appendix A6 suitability (D1-D4) and data-contribution (D5-D9) criteria, the MDCG 2020-6 evidence hierarchy, where risk-of-bias tools fit, and the pre-defined weighting scheme a Notified Body accepts.
September 16, 2026 · 8 min read
Clinical Evidence and Regulation
How to Calculate the Sample Size for a PMCF Study
The MDCG 2020-7 PMCF plan asks for a sample-size rationale: precision-based calculation, the rule of three for zero events, event-driven survival endpoints, and acceptance criteria tied to the CER and ISO 14971. With formulas and worked numbers.
September 16, 2026 · 7 min read