Article 61 requires clinical evaluation to support conformity with relevant MDR general safety and performance requirements, evaluation of undesirable side-effects, and acceptability of the benefit-risk ratio.
This overview helps structure clinical data, equivalence claims, PMCF feedback, the clinical evaluation report, and notified body review evidence.
Structured answer sets in this page tree.
Cited legal and guidance references.
under the EU MDR is a planned lifecycle process that connects intended purpose, clinical data, risk management, , and technical documentation so the manufacturer can show safety, performance, clinical benefit where applicable, and an acceptable benefit-risk profile.
Article 61 ties directly to MDR Annex I. The evaluation must use sufficient to confirm conformity with relevant general safety and performance requirements, assess undesirable side-effects, and support the acceptability of the benefit-risk ratio under normal intended use.
Annex XIV turns that obligation into a method: plan the evaluation, identify which GSPRs need clinical data, search for available clinical data and evidence gaps, appraise the data, generate additional data when needed, and analyse the evidence into conclusions on safety, clinical performance, and clinical benefits.
For implantable and class III devices, Article 61(4) generally requires clinical investigations unless a specific Article 61(4)-(6) route applies. Those routes have separate conditions; prior marketing, a familiar product type, or an claim does not by itself remove the investigation requirement.
MDR clinical data can come from clinical investigations of the device, clinical investigations or other studies reported in scientific literature for an equivalent device, peer-reviewed literature on clinical experience with the device or an equivalent device, and clinically relevant PMS information including .
has strict conditions. Annex XIV requires technical, biological, and clinical characteristics to be considered, and MDCG 2020-5 stresses that differences must be identified, scientifically justified, and shown not to create clinically significant differences in safety or clinical performance.
Article 61 requires the , its results, and the derived from it to be documented in a clinical evaluation report. Except for custom-made devices, that report is part of the technical documentation for the device.
A useful CER connects the plan, literature search and appraisal, investigations, rationale if used, PMS and outputs, state of the art, IFU and claims, risk management, GSPR support, limitations, and benefit-risk conclusion.
Article 61(10) permits reliance on non-clinical testing alone only when the manufacturer can justify that approach from risk management, the device's interaction with the human body, intended clinical performance, and claims. The technical documentation must contain the justification, and the clinical-evaluation duty still applies.
is part of the lifecycle. Annex XIV describes PMCF as the continuous process that updates the clinical evaluation, and the PMCF plan must be addressed in the manufacturer's PMS plan.
should proactively collect and evaluate clinical data from the use of the CE-marked device within its intended purpose. The results feed the PMCF evaluation report, the CER, technical documentation, risk management, and benefit-risk reassessment. Annex II and Annex III allow a documented justification when PMCF is not applicable, but a silent omission or a statement that the device is already CE marked is not that justification.
Where a notified body assesses the device, is a core review area. Annex VII and conformity assessment annexes require notified bodies to review , challenge where claimed, verify GSPR conclusions, consider risk management, IFU, user training, PMS, adequacy, and decide whether milestones are needed for post-certification clinical evidence updates.
For class III implantable devices and class IIb active devices intended to administer or remove a medicinal product, Article 54 adds a consultation procedure unless an Article 54(2) exception applies. Exceptions cover specified certificate renewals, certain modifications of a device already marketed by the same manufacturer for the same intended purpose, and device types whose clinical-evaluation principles are addressed by a common specification and whose evaluation complies with it. The notified body's clinical evaluation assessment report documents the manufacturer's , benefit-risk determination, consistency with intended purpose and medical indications, and plan.
Turn the Article 61 and Annex XIV clinical evaluation structure into a traceable evidence model for clinical claims, GSPR support, PMCF, risk management, and notified body review.
"benefit-risk determination"
"Clinical Evaluation - Equivalence"
"PMCF plan"
"Clinical evaluation consultation procedure"