BEP vs BER: What Is the Difference in ISO 10993?

BEP and BER: Why the Confusion Exists

The Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) are two distinct, mandatory documents under ISO 10993-1. Yet they are routinely confused, merged, or poorly structured in technical files. That is one of the most common reasons manufacturers receive notified body queries and FDA additional information requests.

The BEP: Biological Evaluation Plan

The BEP is written before the evaluation is carried out. It is the planning document that defines the biological evaluation strategy for the device.

What the BEP should include

• Device description: patient-contacting materials, contact type, contact duration, intended use, and relevant patient population.
• Endpoint identification: which ISO 10993-1 endpoints apply to the device and why.
• Evaluation strategy: how each endpoint will be addressed through existing data, literature, chemistry, or new testing.
• Waiver planning: which endpoints are expected to be waived and the scientific basis that will need to support that approach.
• Applicable frameworks: the relevant ISO 10993 subparts, FDA guidance, EU MDR context, and internal risk-management alignment.

The BEP is the document that says: this is how the device will be evaluated. It should be reviewed and approved before the biological evaluation is executed, not written afterward as an administrative formality.

The BER: Biological Evaluation Report

The BER is written after the biological evaluation is complete. It is the scientific report that presents the evidence reviewed and the conclusions reached for the finished device.

What the BER should include

• Evidence reviewed: literature, existing biocompatibility data, material information, chemistry data, and any relevant equivalence arguments.
• Test results and interpretation: where biological testing was performed, the report must explain the relevance of those results to the actual device.
• Waiver justifications: the real scientific argument for endpoints that were not tested.
• Endpoint-by-endpoint conclusions: whether each applicable biological risk has been adequately addressed.
• Overall biological safety conclusion: whether the device is biologically safe for its intended use, based on the evidence assessed.

The BER is the document that says: this is the evidence, this is how it was interpreted, and this is the conclusion.

Quick Comparison: BEP vs BER

• Timing: the BEP comes first; the BER comes after the evaluation is completed.
• Purpose: the BEP defines the strategy; the BER documents the evidence and conclusions.
• Tone: the BEP is prospective; the BER is analytical and retrospective.
• Regulatory value: the BEP shows the evaluation was planned appropriately, while the BER shows whether the final safety position is defensible.

The Single Most Common Mistake

The most common mistake is submitting a BER without a BEP, or submitting a single combined document that tries to act as both. Under EU MDR and current ISO 10993 expectations, reviewers want to see that the biological evaluation was planned before the evidence was assembled. A BER without a prior BEP can make the evaluation look reverse-engineered to support a predetermined conclusion.

What Reviewers Expect to See

Strong submissions make the logic visible. The reviewer should be able to follow the thread from device materials and contact classification, to the planned endpoint strategy in the BEP, to the evidence review and final conclusions in the BER. When that sequence is missing, even good science can look weak.