EU MDR Clinical Evidence

Start with Article 61 and Annex XIV: identify the GSPRs that need clinical data, specify the device's intended purpose and target groups, define measurable clinical benefits and safety endpoints, and justify the level of clinical evidence needed for the device's characteristics, classification, intended purpose, and risks.

The clinical evaluation should then show the route used to reach the conclusion: available clinical data for the device, clinical data for an equivalent device where equivalence is demonstrated, clinical data from similar devices where it informs state of the art or study design, and any new clinical investigation data needed to close evidence gaps.

Keep the terms separate in the working file. Clinical data are the safety or performance information generated from a device's use, clinical investigations, or qualifying published experience. Clinical evidence is the clinical data plus the clinical evaluation results that are sufficient, in amount and quality, to support conformity. Relevance, appraisal quality, and traceability to the intended purpose and GSPRs determine whether a large literature set supports sufficient clinical evidence.

For implantable and class III devices, Article 61(4) starts from a clinical-investigation requirement, then provides defined exceptions. The CER should identify the exact route: modification of a device already marketed by the same manufacturer with demonstrated equivalence and notified-body endorsement; reliance on another manufacturer's MDR device under the Article 61(5) contract and PMCF conditions; or one of the Article 61(6) device categories where sufficient clinical data and any applicable common specification support the exception. The exception does not remove the duty to conduct and update the clinical evaluation.

Where a clinical investigation is needed, Annex XV expects a scientifically sound investigation plan aligned with the clinical evaluation plan and designed to confirm or refute the manufacturer's claims on safety, performance, clinical benefits, and benefit-risk. The investigation report should critically evaluate all collected data, including negative findings.

Equivalence is not a shortcut to avoid evidence. Annex XIV requires technical, biological, and clinical characteristics to be considered, and MDCG 2020-5 emphasizes that differences must be fully identified, assessed, and scientifically justified so they do not create clinically significant differences in safety or clinical performance.

For each presumed equivalent device, keep a separate equivalence table and do not assemble equivalence from different devices for different features. Sufficient access to the data supporting equivalence is required under Annex XIV. The additional Article 61(5) contract for full, ongoing access to another manufacturer's technical documentation applies when an implantable or class III device uses that specific route to avoid a new clinical investigation; it should not be described as a universal contract requirement for every equivalence analysis.

PMCF is a continuous process that updates the clinical evaluation after CE marking. The PMCF plan should state why each activity is needed, which residual clinical uncertainties it addresses, what data quality and quantity are expected, how bias and missing data will be controlled, and when data will be analysed and reported.

The PMCF evaluation report should feed back into the clinical evaluation report, the risk-management file, the benefit-risk conclusion, IFU and labelling decisions, SSCP where applicable, PMS outputs, and corrective or preventive action decisions. For class III and implantable devices, Article 61 requires at least annual updates of the PMCF evaluation report and, if indicated, the SSCP; other devices still need lifecycle updates when new evidence or risk information changes the evaluation.

Where a notified body reviews the device, expect scrutiny of the clinical evaluation as part of the technical documentation assessment and surveillance. The MDR requires notified bodies to examine clinical evaluation planning, literature methodology, clinical investigations, equivalence, PMS and PMCF, clinical evaluation reports, and justifications for not performing clinical investigations or PMCF.

For higher-risk devices subject to clinical evaluation consultation, the notified body's clinical evaluation assessment report can be reviewed by an expert panel. The package should therefore make the benefit-risk conclusion, consistency with intended purpose and medical indications, PMCF plan, and residual evidence gaps easy to follow.