Technical documentation section 6. Verification & validation:

6.3 Biological evaluation report

The biological evaluation report (BER) is a final document that summarizes the results of the biological evaluation of a medical device in accordance with ISO 10993 series and the applicable requirements of Regulation (EU) 2017/745 on medical devices (MDR). It serves to demonstrate that the device is biologically safe for its intended use throughout its entire life cycle.

Purpose and scope

The BER consolidates all available biological data, including the results of biological testing, literature evidence, chemical characterization, and risk assessments. It provides a comprehensive conclusion on whether the biological risks associated with the device have been adequately addressed.

Summary of biological testing

The report includes a summary of all biological tests conducted as part of the evaluation process. These may include, depending on the nature and duration of body contact:

• cytotoxicity
• sensitization
• irritation or intracutaneous reactivity
• acute systemic toxicity
• subacute and subchronic toxicity
• genotoxicity
• implantation studies
• hemocompatibility

For each test, the report provides an overview of the test method, justification for its selection, the test results, and an interpretation of their significance for the overall biological risk profile of the device.

Integration of data and conclusion

The BER integrates the biological test results with chemical characterization data, toxicological risk assessments, and other relevant sources of evidence. It concludes whether the device meets the General Safety and Performance Requirements related to biological safety as defined in Annex I of the MDR.

If any residual biological risks remain, the report must provide a clear justification based on a benefit-risk analysis and describe any risk control measures implemented.

Final statement

The report must be signed by a qualified expert with documented knowledge of biological evaluation, toxicology, and the relevant regulatory framework. It forms a critical part of the device’s technical documentation and should be updated if new biological risks are identified or modifications are made to the device or its materials.