Strengthened analytical and chemical characterisation
The publication of ISO 10993-1:2025 marks a significant milestone in the evolution of biological evaluation principles. Rather than merely updating test requirements, the revised standard reshapes the philosophy of biological safety evaluation to better reflect the expectations of Regulation (EU) 2017/745. Manufacturers must now demonstrate an integrated understanding of materials, manufacturing processes, patient exposure profiles and toxicological risks.
One of the most notable changes is the heightened emphasis on analytical and chemical characterisation. The standard calls for detailed identification and quantification of constituents, impurities, degradation products and leachables. This aligns directly with MDR Annex I, which requires manufacturers to minimise chemical and biological risks as far as possible. The focus has shifted to data-driven justification, where chemistry plays a central role in determining what additional biological testing is truly necessary.
Shift toward risk-based biological evaluation
ISO 10993-1:2025 reinforces the requirement to conduct biologically focused risk assessments that integrate chemical, toxicological and clinical information. This aligns with MDR Annex I and Article 10, which expect risk management and clinical evaluation to inform each other throughout the device lifecycle. Manufacturers must clearly articulate scientific assumptions, justify testing decisions and demonstrate that all identified biological hazards are adequately addressed.
Requirements for a robust BEP and BER
The revised standard places substantial weight on the Biological Evaluation Plan and Biological Evaluation Report. These documents must present a cohesive scientific narrative, linking material data, exposure scenarios, toxicology and any biological test results. Notified bodies are expected to critically evaluate the logic and evidence within these documents; therefore, clarity, completeness and traceability are essential.
Implications for implantable and class III devices
Devices with long-term or permanent exposure, including implantable and Class III devices, face heightened expectations. These technologies often involve multiple materials, coatings or interfaces with tissue. ISO 10993-1:2025 now requires manufacturers to comprehensively justify material selection, evaluate degradation pathways and demonstrate long-term biocompatibility supported by analytical and toxicological evidence.
Lifecycle integration and Post-Market Surveillance
Biological evaluation is now framed explicitly as a lifecycle activity. Manufacturers must integrate post-market surveillance findings, complaint trends, clinical follow-up data and new scientific knowledge into ongoing biological safety assessments. This mirrors the MDR’s focus on continuous conformity and dynamic risk management.
Preparing for implementation
To prepare for the transition, manufacturers should review existing BEPs, update material datasets, verify analytical test capabilities and assess whether historical biological testing strategies remain adequate. Many organisations may require deeper toxicological expertise or updated chemical analysis to meet the new requirements.
Conclusion
ISO 10993-1:2025 represents a decisive shift toward scientifically grounded, transparent and lifecycle-focused biological evaluation. By demanding more robust evidence and clearer justification, it supports the MDR’s overarching goal of reinforcing patient safety while ensuring regulatory consistency across the EU market.