Since its release in late 2025, ISO 10993-1:2025 has redefined the biological evaluation of medical devices. No longer a “future requirement”, the 2025 revision is the foundational standard for assessing body-contact safety. With the June implementation deadline only weeks away, it is now a critical milestone for market access.
The 2025 update represents a significant shift in regulatory expectations. By integrating more closely with ISO 14971, the standard officially moves the industry away from “check-the-box” matrix testing. Instead, it mandates a science-driven, risk-based approach with comprehensive chemical characterisation and toxicological risk assessment (TRA) as the mandatory first steps for demonstrating biocompatibility.
As this transition window closes, manufacturers must move beyond gap assessments and finalise their documentation. Failure to align with these science-based justifications can lead to:
- Critical delays in new product clearances.
- Regulatory challenges for legacy devices.
- Unforeseen supply chain disruptions.
How SAXOCON Can Help
Whether you are finalising a Biological Evaluation Report (BER) or need a last-minute toxicological strategy, our experts specialise in navigating these new requirements.
Our Medical Device Services ensure your portfolio remains compliant and market-ready.