Lot-by-lot verification of third-risk-class in vitro diagnostic medical devices: international experience, rationale, and implementation proposals for the Russian Federation

Objective. To analyze international approaches to lot‑by‑lot quality control of high‑risk in vitro diagnostic medical devices and to assess the feasibility of implementing lot verification in the Russian Federation. The review also considers lot‑to‑lot variability as a factor affecting the reliability of laboratory testing.

Materials and methods. An analytical review was conducted, including scientific publications, international models of lot‑by‑lot control applied across various regulatory jurisdictions, and data from Russian state surveillance reports on substandard lots of in vitro diagnostic devices for the period 2015–2025. International models were compared according to independence of expertise, organizational feasibility, throughput capacity, and the ability to prevent the release of lots with deviating performance characteristics.

Results. Lot‑by‑lot verification of third‑risk‑class in vitro diagnostic medical devices is a key mechanism for ensuring the reliability of laboratory testing and reducing the likelihood of diagnostic errors. International and Russian data indicate that lot‑to‑lot variability is a significant risk factor capable of reducing the sensitivity and specificity of diagnostic assays. Despite the existing mechanisms of state registration and post‑market surveillance, in the Russian Federation lot‑related defects are predominantly detected only during clinical use.

Conclusion. The implementation of independent lot‑by‑lot verification represents a justified and necessary measure for improving the quality of diagnostic devices and enabling timely prevention of clinically significant deviations.

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