Revision of ISO 10993-1: Why the 2025 update matters for MDR alignment

ISO 10993-1 is the international standard that is used as a framework for assessing the biological safety of medical devices that come into direct or indirect contact with the human body. As contact between the device and the patient can result in harmful biological effects, manufacturers must plan and document a Biological Evaluation Plan (BEP). This plan must identify hazards and exposure, as well as acceptance criteria. ISO 10993-1 is regarded as the "state-of-the-art" standard for biocompatibility, and as such, it is considered best practice for creating a BEP. It is widely relied upon by regulators and conformity assessment bodies worldwide.

The sixth edition of the ISO 10993-1, published in November 2025, has undergone a detailed restructuring to incorporate biological evaluation within a risk management framework and to even more closely align terminology and concepts with ISO 14971. Notably, ISO 14971 is the international standard that establishes principles for the risk management process of medical devices throughout their entire life cycle.

One of the most important updates in the new revision of ISO 10993-1 involves the incorporation of considerations relating to reasonably foreseeable misuse in biological evaluations. The 2025 edition explicitly requires that biological evaluations consider not only the intended use of a product, but also reasonably foreseeable misuse. This does not imply that medical device manufacturers must consider every possible situation; however, it does expand the hazard analysis in such a way that evaluators must now consider how typical or predictable misuses might change exposure and therefore biological risk.

Moreover, the revision strengthens the foundations of biological evaluation by refining how exposure duration is defined and assessed (including intermittent contact) and by reinforcing expectations for detailed materials characterization and upfront biological hazard identification. Together, these updates support more targeted, risk-based selection of biological endpoints and testing strategies.

In Annex I, the EU Medical Device Regulation (MDR, EU 2017/745) requires that manufacturers must demonstrate the identification, assessment and control of biological risks and incorporate these assessments into the technical documentation. If a Biological Evaluation Plan (BEP) does not align with the requirements of the revised ISO 10993‑1:2025, there is an increased risk that the corresponding section of the technical documentation may be considered non-compliant.

The MDR does not prescribe the exact format of a Biological Evaluation Plan (BEP); industry therefore relies on ISO 10993-1 as “state-of-the-art” normative reference when preparing a BEP for conformity assessment. Because the 2025 edition explicitly aligns the biological evaluation with ISO 14971 risk management principles and tightens BEP expectations, adopting the new ISO text helps manufacturers show that their biological risk assessments meet contemporary “state-of-the-art” practice referenced in regulatory review.

What does this exactly mean?
Following ISO 10993-1:2025 makes it easier to demonstrate that biological risks were handled in a risk-based, traceable manner.

In conclusion, ISO 10993-1:2025 reframes biological evaluation as an integrated part of device risk management. For teams preparing MDR technical documentation, the revision raises the bar for the BEP, encourages more robust materials data and requires explicit consideration of foreseeable misuse and exposure accumulation.