Biological evaluation report (BER)

A biological evaluation report (BER) or biological risk assessment report (BRA) collects and evaluates the results of biological evaluation studies and concludes the medical device's biological risk. It is a comprehensive analysis considering chemical and biological test results as well as toxicological evaluation of the extractables that could be released from the device during its usage.

The biological evaluation report is needed as a part of the regulatory approval and often requires strong expertise in the biological risk evaluation of medical devices, taking into account the requirements of ISO 10993- standard family and local regulations (FDA, MDR).

The biological evaluation plan (BEP) and sufficient testing need to be completed before the BER can be prepared.

Measurlabs can support medical device manufacturers with BER preparation. We can also provide the required testing and a BEP if these have not yet been completed.