Once the Biological Evaluation Plan defines the strategy, the Biological Evaluation Report (BER) is where that strategy delivers its conclusion. The BER template provides a structured framework for documenting that conclusion, bringing together all generated test results and data into a definitive assessment of a device’s biological safety.
Under Regulation (EU) 2017/745 Annex I and ISO 10993-1, this template documents the critical analysis of test results against applicable biological endpoints, toxicological risk assessment, and a scientifically justified conclusion on the overall biocompatibility of the device for its intended use. Justification for any deviations or omitted tests is captured, ensuring the evaluation remains complete and transparent.
Traceability between biological risks, test outcomes, and final safety conclusions is maintained throughout, keeping the BER consistent with the BEP and ISO 14971 risk management outputs.
Developed by experienced regulatory professionals, this template ensures manufacturers present a biocompatibility conclusion that is scientifically sound and holds up under Notified Body review.
Price: $250
