How will ISO 10993-1:2025 affect the future of preclinical medical device compliance?

Daniele Lioi, Senior Consultant and Business Unit Manager, Eurofins Medical Device Services, daniele.lioi@mds.eurofinseu.com

The publication of ISO 10993‑1:2025 marks a major turning point in the way manufacturers approach the biological safety of medical devices. Far from being a simple revision, the new edition reshapes the evaluation process into a fully integrated, risk‑based, and lifecycle‑oriented framework aligned with ISO 14971. For companies operating in an increasingly complex regulatory environment, the standard sets clearer expectations and offers opportunities to improve efficiency, reduce unnecessary testing, and strengthen compliance.

The Biological Evaluation Plan (BEP) is now a mandatory and central element of the evaluation process. The BEP anchors together device description, intended use, hazard identification, acceptability criteria, and testing strategy. Furthermore, the introduction of reasonably foreseeable misuse forces the biological risk assessor to consider systematic human use within the factors of impact on biocompatibility.

The new edition also embraces a lifecycle perspective, requiring manufacturers to continuously reassess biological risks from early design stages through post‑market activities. Material changes, degradation, reprocessing, and post-market feedback now play an integral role in maintaining biological safety.

Another critical innovation is the introduction of biological equivalence, allowing companies to justify the safety of a device through comparison with established reference products. Combined with enhanced chemical characterisation requirements and toxicological risk assessment, this approach can significantly reduce unnecessary animal or clinical testing, provided the equivalence is robustly documented.

The revision also modernises exposure categorisation by focusing on contact days, intermittent exposure, and bioaccumulation potential. This ensures a more realistic - and sometimes more conservative - assessment of long‑term risks, especially for devices used repeatedly over short intervals.

Finally, the standard reinforces the use of New Approach Methodologies (NAMs), in vitro systems and in silico tools that support the global trend toward reducing animal testing while improving human relevance.

While the regulatory landscape continues to evolve, many manufacturers are discovering that navigating biological risk assessment under ISO 10993 1:2025 requires not only technical expertise but also a strategic, well structured approach.

Eurofins Medical Device Services is equipped to support you across the entire process - from defining a robust Biological Evaluation Plan to guiding equivalence strategies, analysing chemical and toxicological data, and integrating post market evidence into a compliant lifecycle evaluation. With multidisciplinary expertise spanning toxicology, regulatory affairs, and device development, we help transform complex requirements into clear, actionable pathways. Partnering with us means accelerating your route to conformity, while ensuring the highest standards of patient safety and regulatory confidence.

For more information, visit: www.eurofins.com/medical-device or contact us at: medical-device@mds.eurofinseu.com