The ISO 10993-1:2025 standard includes a clear and important shift in how the biological evaluation process is expected to be planned, performed, and documented. Toxicological expertise can no longer be considered a peripheral part of the overall process. In fact, a qualified toxicologist’s input is now explicitly central to it. Regulatory reviewers are directed to look for evidence that a qualified toxicologist has been directly involved in the preparation, review, and scientific justification of both the Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER). Not just the Toxicological Risk Assessment (TRA) portion. This is especially critical because ISO 10993-1:2025 adopts a risk-based evaluation framework, where decisions must be supported by robust and defensible scientific rationale rather than simple checklists or legacy approaches.
One of the most significant implications of this update is the growing emphasis on Sponsor demonstration of Subject Matter Expert (SME) input throughout the biological evaluation process. It’s not enough to compile data. Regulators want confidence that conclusions about biological safety have been drawn by appropriately qualified experts. A toxicologist’s authorship or review of the BEP and BER signals that all testing related to biological effects has been properly planned, interpreted, and integrated into the overall biological evaluation strategy, and that data originating from other sources such as the scientific literature, clinical use, or a predicate device(s) is relevant, reliable, and robust. Companies who submit without demonstrating appropriate SME input may face increased agency scrutiny, requests for additional information, or costly delays during review.
This is where Canyon Labs provides clear value. Our team brings dedicated toxicological expertise into the BEP and BER process from the beginning, providing a set of options that can be tailored to your needs. The most turn-key option is to have a Canyon Labs toxicologist write your BEP or BER from beginning to end, providing their expertise every step of the way and signing the final document as the author. Alternatively, a Sponsor may elect to write the BEP or BER themselves, with a Canyon Labs toxicologist reviewing the document at appropriate points and providing feedback and recommendations to ensure that the report is structured, justified, and documented in alignment with ISO 10993-1:2025 expectations. As an add-on option for this approach, a Canyon Labs toxicologist can co-sign the final document as a reviewer, demonstrating that the finished product was produced with the input of a qualified SME toxicologist.
By involving a toxicologist early in the BEP/BER process, Canyon Labs helps you reduce gaps, streamline submissions, and build documentation that is tailored to meet your specific regulatory needs. As agency expectations and international standard requirements continue to increase, having the right toxicological expertise involved is critical.