ISO 10993-1:2025 — What the new guidance means for medical device biological evaluation
ISO 10993‑1:2025 introduces significant updates to the biological evaluation of medical devices, including stronger integration with ISO 14971 risk management, a redefined exposure approach based on contact days, clearer device categorization with updated biological endpoints, structured criteria for biological equivalence, and expanded guidance for sensitive populations. This overview summarizes the key changes and explains how manufacturers can align with the revised expectations through well‑justified documentation, risk‑based assessment, and expert support.
ICH Q3E Guideline: Extractables & Leachables
The draft ICH Q3E Guideline establishes a harmonized, risk-based framework for managing extractables and leachables (E&L) throughout the lifecycle of drug products. Covering study design, toxicological qualification, acceptable exposure limits, and lifecycle monitoring, Q3E provides manufacturers with a consistent approach to assessing E&L risks while supporting patient safety and regulatory compliance.