Evolution of the biological evaluation of medical devices to ISO 10993-1:2025
£50.00
A clear, practical analysis of ISO 10993-1:2025, explaining its integration with risk management, lifecycle thinking, and structured biological evaluation planning for stronger regulatory compliance
English
The evolution of biological evaluation for medical devices finds a crucial turning point in the publication of ISO 10993-1:2025, as explained by Paolo Pescio in his latest article for the Journal of Medical Device Regulation. This new edition of the standard consolidates the alignment process with the overall risk management system, introducing a close integration between biocompatibility assessment and risk management processes. The systematic approach promoted by ISO 10993-1:2025 is reflected in the formalisation of the Biological Evaluation Plan, which becomes the documentary and methodological core through which acceptability criteria, device categorisation, hazard identification, and planning of evaluation strategies are defined. Adoption of the terminology and principles from ISO 14971 enables the standardisation of procedures, reducing interpretative variability and ensuring more objective and repeatable assessments. It becomes essential to consider reasonably foreseeable misuse alongside the intended use of the device. Among the main innovations of the sixth edition is the explicit requirement to integrate biological evaluation as an integral part of the medical device lifecycle, from design to decommissioning, thus strengthening regulatory compliance and reducing the risk of non-conformity. The biological evaluation process is based on a systematic collection of chemical, physical, and biological data; where these prove insufficient, additional testing is foreseen, according to a risk control hierarchy consistent with ISO 14971. The process goes ahead with the drafting of the Biological Evaluation Report, which transparently documents the decisions and measures adopted, ensuring traceability and verifiability of the choices made. The biological evaluation is then reviewed whenever changes to design, production processes or emerging post-market information can impact biological safety.
Specification: 10 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the February 2026 issue of the Journal of Medical Device Regulation.
