Technical documentation section 6. Verification & validation:

6.1 Biological evaluation plan for medical devices

The biological evaluation plan (BEP) is a key component of MDR-compliant technical documentation. It outlines the strategy for assessing the biological safety of a medical device in accordance with the principles of the ISO 10993 series and the requirements of Regulation (EU) 2017/745 on medical devices (MDR).

Concept and regulatory role

Under MDR, the manufacturer must demonstrate conformity with the General Safety and Performance Requirements (GSPRs), including those related to biological safety (Annex I, Chapter II, points 10 and 11). The BEP provides a structured plan for how biological safety will be established, covering both the rationale for testing and any justifications for not conducting certain tests based on existing data.

Structure and content

The structure of a biological evaluation plan may vary, but an MDR-compliant BEP typically includes the following elements:

• Identification and description of the medical device
• Definition of the intended purpose and clinical context of use
• Classification of the device according to type and duration of body contact (as per ISO 10993-1)
• Detailed materials description and manufacturing overview
• Identification of biological endpoints relevant to the device category
• Assessment of existing biocompatibility data and literature
• Gap analysis to determine if additional testing or justification is needed
• Plan for further testing (if required), including standards to be followed
• Justification of the overall biological evaluation approach

Integration with ISO 10993 series

ISO 10993 provides the framework for biological evaluation of medical devices. ISO 10993-1 is especially important, as it guides the selection of relevant biological endpoints and promotes a risk-based approach. MDR references harmonised standards such as ISO 10993 as a presumption of conformity, and following these standards is essential for demonstrating compliance with GSPR requirements.

The BEP acts as a roadmap for how the manufacturer will meet these requirements. It ensures that biological risks are evaluated appropriately before the device is placed on the market, and that decisions regarding testing or literature-based justifications are properly documented and scientifically sound.

Connection to clinical evaluation and risk management

The BEP is linked to the clinical evaluation and risk management processes defined under MDR. It contributes to the overall assessment of benefit-risk ratio and supports clinical evidence by demonstrating that no unacceptable biological risks exist. Findings from the biological evaluation, once completed, are reported in the biological evaluation report (BER) and referenced in the clinical evaluation report (CER).

Conclusion

The biological evaluation plan is a foundational document under MDR, ensuring that biological safety is addressed systematically and in alignment with harmonised standards such as ISO 10993. A well-prepared BEP strengthens the technical documentation, supports the conformity assessment process, and contributes to the safety and regulatory acceptance of the medical device.