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Medical Devices

Biocompatibility in Transition – Integrating Biological Safety, Post-Market Evidence, and Advanced Risk Assessment

Friday, May 8, 2026
11:15 - 12:15 WEST
Location: Auditorium 2
Learning Level: Advanced
Description: ISO 10993-1:2025 introduces substantial conceptual and practical changes to biological risk assessment, strengthening alignment with ISO 14971, integrating post-market and clinical evidence, and redefining risk-based decision making across device categories. This session provides a consolidated view of the upcoming revision: an overview of major changes and their implications for manufacturers, practical guidance on how to incorporate clinical evaluation, PMS and PMCF data into biological evaluation updates, and a deep dive into complex areas such as the assessment of nanomaterials using the new workflow and risk-table structure. Through case studies and expert perspectives from toxicology, regulatory consulting, and a notified body, attendees will gain an actionable understanding of what ISO 10993-1:2025 means for both new and legacy devices and how to prepare their technical documentation accordingly.

Learning Objectives:

  • Identify and interpret the key changes introduced in ISO 10993-1:2025 on both new and legacy devices, including updated risk-based structures, new effects, and alignment with ISO 14971.
  • Apply clinical evaluation, PMS and PMCF data to biological evaluation updates and understand when lifecycle evidence necessitates revision of BE reports.
  • Assess complex technologies, such as devices incorporating nanomaterials, using ISO 10993-1:2025 workflows, and avoid common technical-documentation pitfalls.