What is a Biological Evaluation Plan?

A Biological Evaluation Plan (BEP) is a key step in the regulatory pathway for a medical product and is required by ISO 10993-1. The BEP summarizes the material composition, as well as the existing pre-clinical and clinical data for a device, and outlines the plan to complete an evaluation of the biological safety risk posed by a device. An effective BEP proactively identifies potential biological risks and strategizes the most efficient testing scheme, eliminating redundancy in costly clinical studies, while still maintaining high assurance of patient safety.

In preparing a BEP, Cambridge Polymer Group specialists examine the medical product’s composition, manufacturing process, design, packaging, and intended clinical use, as well as supporting information that the client may have regarding clinical history or existing test results. This information is used to plan a set of tests that is both compliant with ISO 10993-1 and is specific to the medical product and indication (usage) in question.

In addition to FDA regulatory filings, Cambridge Polymer Group’s biocompatibility specialists can assist with Medical Device Reporting (MDR) remediation requests. Our scientists are experienced in identifying an efficient plan for the essential tests, minimizing costs and delays, while always being aware of the criticality of patient safety. A plan can be put into place for new devices, existing devices needing updates, or those undergoing material or process changes.

We routinely work with your existing regulatory or development teams, or interface with our own approved vendors to support your project. In this role, we provide an independent third party and qualified expert opinion to assemble the BEP and can assist you in finding the appropriate vendors to conduct the biocompatibility testing. The execution of the BEP results in a Biological Evaluation Report (BER).

Biological Evaluation Report – Biological Risk Assessment

This report assesses your device’s biological safety using a risk-based approach outlined in ISO 10993-1:2018. We consider physical and chemical information, biological testing results, and existing data to create a robust safety profile. Following ISO 14971:2019 Clause 5.5, we incorporate various data sources: published research, scientific data, clinical evidence, and expert opinion. This ensures a comprehensive and defensible risk assessment.

The BER becomes a vital component of your regulatory submission, paving the way for a smooth approval process and providing a document that can be readily revised in the event of a subsequent material or processing change.

  • ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
  • ISO 14971:2019 Medical devices-Application of risk management to medical devices

Contact CPG

Partner with Cambridge Polymer Group for your BEP/BER/BRA needs. Email or call us at 617-629-4400.