Every medical device that contacts the body needs a documented biological evaluation. Under ISO 10993-1 that evaluation is a planned, risk-based process, and it is usually captured in two documents: a Biological Evaluation Plan (BEP) written before any testing, and a Biological Evaluation Report (BER) written once the evidence is in.

What is a Biological Evaluation Plan (BEP)?

The BEP is the strategy. It describes the device, sets out how the biological risks will be assessed, and explains which evidence will be used to address each one. A good BEP is written early, ideally during design, so that material choices and test plans are made with the biological evaluation in mind.

A typical BEP covers:

  • Device description, intended use and the materials of every patient-contacting component
  • Categorisation by nature of body contact and duration of exposure
  • The biological endpoints relevant to that category
  • Existing data that can be used: material history, previous testing, literature and equivalence to marketed devices
  • The chemical characterisation plan (ISO 10993-18) and toxicological risk assessment approach (ISO 10993-17)
  • Any biological tests still needed, with a scientific justification for each endpoint that is not tested

What is a Biological Evaluation Report (BER)?

The BER is the conclusion. It brings together everything gathered under the plan, interprets it, and states whether the device is biologically safe for its intended use. Reviewers at notified bodies, the US FDA and CDSCO read the BER to understand how the manufacturer reached that conclusion.

  • Results of chemical characterisation, extractables and leachables studies
  • The toxicological risk assessment of identified compounds
  • Biological test results and their interpretation, including any borderline findings
  • Literature and clinical or post-market data used as evidence
  • Residual risks, how they are controlled, and the overall biological safety conclusion

How the BEP and BER differ

  • Timing: the BEP is written before evidence is generated; the BER after it is complete.
  • Purpose: the BEP justifies the strategy; the BER justifies the conclusion.
  • Audience: the BEP guides your own team and test laboratories; the BER is written for the regulator.

Both documents are living records. A change of material, supplier, sterilisation method or manufacturing process can mean the plan and report need updating, and post-market data should feed back into them.

Why regulators expect both

Submitting test reports alone rarely satisfies a reviewer. What they want to see is the reasoning: why each endpoint was addressed the way it was, and why the evidence is enough. A clear BEP and BER make that reasoning easy to follow, which shortens review cycles and reduces deficiency questions.