Biocompatibility testing requirements vary by device. This template provides a structured framework for determining which tests are necessary, which can be waived, and the scientific basis behind each decision.
Under ISO 10993-1 and Regulation (EU) 2017/745 Annex I, test identification is driven by factors including the nature and duration of body contact, and intended clinical use. It covers the systematic identification of applicable biological endpoints such as toxicity, sensitisation, irritation, etc.
This template ensures manufacturers document test selection decisions in a structured, traceable manner — providing the evidential foundation upon which the Biological Evaluation Plan is built.
It is developed by experienced regulatory professionals, ensuring Biological test identification is consistent, transparent, and aligned with Notified Body expectations.
Price: $100
