Drafting of the Biological Evaluation Plan and Report (BEP/BER)

Biological evaluation is a fundamental pillar in demonstrating the safety of medical devices. The Biological Evaluation Plan (BEP) and the Biological Evaluation Report (BER) form the core documentation required to demonstrate compliance with the General Safety and Performance Requirements (GSPR) of Regulation (EU) 2017/745 (MDR), and must be developed in accordance with ISO 10993-1.

We offer specialized services for the preparation, updating, and integration of BEP and BER.

• Biological Evaluation Plan (BEP): Analysis of the type, duration, and nature of body contact; identification of biological risks; evaluation of existing data; strategy for additional testing if required; integration with the risk assessment.
• Biological Evaluation Report (BER): Analysis of available data; justification for tests performed or omitted; evaluation of the biological profile's acceptability. 
• Integration with technical documentation: Alignment with the technical file and risk assessment; integration with PMS/PMCF strategies to confirm long-term safety.

Why Choose FTR ADVISOR? Because a strong approach to biological evaluation is not just a regulatory requirement—it’s a key factor for the credibility and clinical acceptance of your device. And we have the expertise to guide you through every step of the process..