ISO 10993-1:2026 introduces important changes to how biological evaluation is planned, justified and documented for medical devices. The updated standard strengthens the link between biological evaluation and risk management, places greater emphasis on chemical characterisation, and introduces new approaches to endpoint selection and contact categorisation.
The 2026 revision of ISO 10993-1 is one of the most consequential overhauls to the global biological evaluation framework in more than a decade – one that fundamentally changes how manufacturers approach biocompatibility across the entire product lifecycle. For manufacturers of long-term, implantable, cardiovascular or otherwise higher-risk devices, the revision is likely to affect testing strategies, documentation and regulatory expectations in both EU and US markets.
In this blog, we look at the key changes in ISO 10993-1:2026 and what they mean in practice.
How does ISO 10993-1:2026 change biological evaluation and risk management?
The most consequential change in ISO 10993-1:2026 is a deeper, mandatory integration between biological evaluation and ISO 14971 risk management. Biological safety can no longer be assessed as a standalone activity or a discrete project phase. Every toxicological conclusion, test decision, and justification must now tie directly to a documented hazard, risk estimate, and risk control action within the risk management file.
The focus shifts from routine testing toward scientifically justified, risk-based evaluation. The standard moves the industry toward a science-driven model built on chemical characterisation as the foundational input, toxicological risk assessment (TRA) anchored in extractables and leachables data, justification-based endpoint selection, and demonstrated linkage to residual risk evaluation.
The 2026 revision also explicitly requires assessment of reasonably foreseeable misuse – meaning manufacturers must now evaluate tissue exposure scenarios arising from improper use, incorrect anatomical placement, or reprocessing deviations. Design and clinical teams can no longer limit their biological evaluation strategy to intended use alone.
What changes in biological endpoints and contact categorisation?
The familiar matrix mapping body contact type and duration to biological test endpoints has been retired. ISO 10993-1:2026 replaces it with multiple contact-type-specific tables covering skin, mucosal surfaces, internal tissues, and circulating blood – each with finer distinctions than the previous single-matrix approach.
The intent is to reduce misinterpretation and harmonise expectations, particularly for devices with complex or multiple contact interfaces. In practice, this will expand testing requirements for some devices and reduce unnecessary testing for others. The change demands a fresh look at how existing devices are categorised – assumptions carried over from the previous version may no longer hold.
Why chemical characterisation becomes more important in ISO 10993-1:2026?
Chemical characterisation is now the core input to biological evaluation strategy, not a supporting exercise. Under the 2026 revision, extractables and leachables data serve as essential inputs to assessments of genotoxicity, carcinogenicity, systemic toxicity, and long-term safety. Manufacturers who have treated chemical characterisation as a box-ticking exercise will need to invest in both the quality and depth of this work.
At the same time, animal testing is formally repositioned as a last resort. Manufacturers must now demonstrate that existing data, in vitro methods, or toxicological modelling cannot adequately address the biological risk before animal studies can be justified. This aligns with the 3Rs principle and reflects the direction of travel in both FDA and EU regulatory thinking.
The revision also gives elevated attention to particulate characterisation – particularly for cardiovascular and blood-contacting devices – reflecting a growing body of evidence on particulate-induced biological responses.
Will EU and FDA expectations differ under ISO 10993-1:2026?
ISO 10993-1:2026 is designed to enable global harmonisation, but the regulatory picture is more complicated in practice. The US FDA has expressed reservations about immediate adoption, citing implementation uncertainties. Manufacturers targeting the US market should therefore prepare dual alignment strategies: demonstrating compliance with the 2026 standard while continuing to meet existing FDA expectations for biological evaluation.
In Europe, adoption is expected to move faster. Notified Bodies will apply heightened scrutiny to:
- Chemical characterisation quality and depth
- TRA methodologies and their scientific justification
- Justification-based evaluations replacing routine testing
- Lifecycle-dependent changes, aging effects, and wear
- Particulate assessment for cardiovascular devices
This divergence between markets makes early, cross-functional regulatory planning essential rather than optional. Waiting until a submission is under preparation is too late.
How should manufacturers prepare for ISO 10993-1:2026?
Transitioning to ISO 10993-1:2026 requires structured action, not just awareness.
Near term
Conduct a gap assessment across your device portfolio – examining new contact tables, exposure duration classifications, particulate requirements, and chemical characterisation depth. Review existing extractables and leachables strategies, and identify devices that may require expanded genotoxicity or systemic toxicity evaluation.
Medium term
Revise Biological Evaluation Reports (BERs) to reflect risk-driven, lifecycle-consistent evaluation. Update validation plans to account for sterilisation effects, wear, reprocessing, and aging. Define regulatory strategies for EU and US submissions under the divergent expectations now in play.
Longer term
Sustainable compliance with the 2026 standard depends on genuine organisational capability – internal or external toxicology expertise, strengthened chemical characterisation programs, tighter integration of biological evaluation with risk management processes, and updated design control checkpoints. Organisations that invest in these capabilities will be better positioned for consistent, predictable regulatory outcomes across development programs.
Although implementation timelines and regulatory expectations may still evolve, early assessment of potential gaps can help avoid delays later in product development or submission preparation. Medfiles supports medical device manufacturers in assessing the impact of new requirements, reviewing biological evaluation approaches, and preparing documentation aligned with evolving regulatory expectations in the EU and beyond.
Author: Eric Schwandt
Manager, Medical Device
Eric Schwandt joined Medfiles in 2022 and is the manager of the Medical Device and IVD Regulatory Team. Eric has a M.Sc. in Oral Biology, focusing on the molecular biology of cancer. For more than 20 years before joining Medfiles, he has held a number of regulatory affairs, QMS management, and marketing positions in the medical device and IVD industry. This has led to particular experience and interest in autoimmune disease diagnostics, POC testing, immunohistochemistry, and radiation and laser product safety.
