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Daniele Lioi, Senior Consultant Medical Devices and Business Unit Manager

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The publication of ISO 10993‑1:2025 marks a significant evolution in how manufacturers approach the biological safety of medical devices. More than a revision, the new edition introduces a fully integrated, risk‑based and lifecycle‑oriented framework, aligned with ISO 14971, setting clearer regulatory expectations while enabling smarter and more efficient compliance strategies. 

A central pillar of this evolution is the Biological Evaluation Plan (BEP), now a mandatory and foundational element of the biological evaluation process. The BEP structurally connects device description, intended use, identification of biological hazards, acceptability criteria, and testing strategy. Importantly, the new standard also requires consideration of reasonably foreseeable misuse, ensuring that biological risks are assessed under realistic conditions of human interaction. 

ISO 10993‑1:2025 further strengthens the lifecycle perspective on biological safety. Biological risks must now be reassessed continuously, from early design through post‑market surveillance, taking into account material or process changes, degradation, reprocessing, and real‑world clinical feedback. Biological evaluation is no longer a one‑time activity, but a living process supporting long‑term patient safety. 

Another key innovation is the reinforced concept of biological equivalence. When supported by robust evidence, equivalence to a suitable reference device may justify the biological safety of a product and reduce unnecessary animal or clinical testing. This approach relies on enhanced chemical characterisation, sound toxicological risk assessment, and clear documentation to meet regulatory expectations.
The revised standard also modernises exposure categorisation, focusing on contact days, intermittent exposure patterns, and bioaccumulation potential. This allows a more realistic, and in some cases more conservative, evaluation of long‑term risks, particularly for devices used repeatedly over short intervals. In parallel, ISO 10993‑1:2025 reinforces the role of New Approach Methodologies (NAMs), supporting the global move toward reducing animal testing while improving relevance to human biology.
A major, and often overlooked, addition in ISO 10993‑1:2025 is the explicit requirement for biological risk estimation (Clause 6.9). This step is essential for translating biological hazards into meaningful, decision‑driven risk information. 

Biological risk estimation must be performed within the ISO 14971 risk‑management framework, integrating all available data, including physical and chemical characterisation, identified hazards, hazardous situations, and potential biological harms. The standard requires assignment of severity and probability, using qualitative or quantitative approaches, while explicitly addressing uncertainty and reasonable worst‑case assumptions.
This step represents a conceptual shift: biological evaluation is no longer purely descriptive, but a structured process that prioritises risks, supports acceptance decisions, and strengthens regulatory justifications. 

At Eurofins Medical Device Services, we support manufacturers across the entire biological evaluation lifecycle, from defining robust BEPs and equivalence strategies to integrating chemical, toxicological, and post‑market data.
In particular, Eurofins Regulatory & Consultancy Services embeds a comprehensive and traceable biological risk estimation into every assessment, ensuring scientific robustness, regulatory clarity, and confidence that no relevant biological risk is overlooked. 

A strong biological risk estimation is not just a requirement, it is a cornerstone of high‑quality biocompatibility strategy. 

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