The MDR raised the bar on clinical evidence sharply. “It worked under the old directive” is no longer enough — every device now needs a defensible, up-to-date clinical evaluation.
Article 61 requires a clinical evaluation for every device, based on clinical data and following the methodical procedure set out in Annex XIV. It is planned, conducted and documented by the manufacturer, and updated throughout the lifecycle with post-market data.
The core deliverables
A clinical evaluation produces a Clinical Evaluation Plan and a Clinical Evaluation Report (CER), supported by a Post-Market Clinical Follow-up plan and report that feed new evidence back into the CER. These are living documents, not a one-time submission.
A higher bar than the MDD
The MDR’s central concept is “sufficient clinical evidence”. For implantable and Class III devices, the default position is that clinical investigations must be performed unless a specific exemption applies. Legacy devices that relied on limited data under the old directive frequently need to close evidence gaps.
The equivalence route — narrowed
Relying on a competitor’s device to demonstrate equivalence is now much harder. Equivalence must be shown on technical, biological and clinical grounds, and for implantable or Class III devices relying on equivalence, the manufacturer must have a contract giving sufficient access to the equivalent device’s technical documentation — a condition that is rarely achievable between competitors.
When an investigation is required
A clinical investigation is generally needed when equivalence cannot be shown or existing data are insufficient — especially for implantable and Class III devices — conducted to ISO 14155 and the relevant MDCG guidance. Guidance documents MDCG 2020-5, 2020-6 and 2020-13 shape how evaluations and legacy evidence are assessed.
How PQRA helps
PQRA develops clinical evaluation plans and reports, assesses evidence gaps and advises on when a clinical investigation is unavoidable.
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