How ISO 10993-1:2025 Impacts Your Regulatory Strategy

The newly published ISO 10993-1:2025 – “Biological evaluation of medical devices - Part 1” introduces several important updates that directly affect how manufacturers plan, justify, and document their biological evaluations. These changes are relevant to all device classes and will significantly influence regulatory submissions and testing strategies.

As ISO 10993-1 is a foundational standard referenced across the EU MDR, IVDR, US FDA guidance, and other global frameworks, understanding the revised structure and intent is essential for maintaining compliance and market access.

Key Technical Revisions and Their Implications

The 2025 revision strengthens the emphasis on a biological evaluation plan (BEP) that integrates risk management, material characterization, and chemical assessment early in the device lifecycle. It also clarifies:

• - The link between chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17).
• - The expectation for data-driven justification when determining the need for in vivo testing.
• - The alignment with biocompatibility evaluation for combination products and devices containing nanomaterials.
• - Updates to Annexes A and C, providing clearer guidance on endpoints, device categorization, and test selection rationale.

• These refinements reinforce the need for a science-based evaluation approach, ensuring that biological safety assessments align with regulatory expectations and scientific best practices.

  Global Implementation Challenges

• While ISO 10993-1:2025 offers an internationally recognized framework, interpretation and enforcement differ across jurisdictions. For example, the European Commission, FDA, and China NMPA each reference the standard but apply distinct evaluation criteria. Understanding these differences is critical during the transition period.

  Our Regulatory Due Diligence Services and EU MDR/IVDR Compliance Training can help you assess how these changes affect your portfolio and submission strategies in different markets.

• Gain Clarity with Qserve’s ISO 10993-1:2025 E-Learning

• To help regulatory, quality, and R&D professionals prepare, Qserve has developed a 2-hour e-learning course that provides practical insight into the 2025 revision. Participants will:
• - Understand the technical updates and their regulatory impact.
• - Learn how to adapt biological evaluation plans in line with the revised standard.
• - Gain clarity on regional regulatory interpretations and transition expectations.
• - Be equipped to document and justify testing approaches with confidence.