What is Biological Evaluation Report?
Following completion of the activities outlines in the Biological Evaluation Plan, a final assessment of the data is given within The Biological Evaluation Report.
The report is a collective summary of all data used to assess the biocompatibility of a medical device. The overall biological risk of the device is considered. The report will include final statements to assess if all risks have been identified and controlled and the device is biologically safe for its intended use.
It is essential that the biological evaluation report is reflected within the risk management process by providing an overall biological risk of the device. The report will include final statements to assess if all potential risks have been identified and all of the risk controls are suitable and effective.
It is important that manufacturers periodically review the biological evaluation to determine if any updates are required. Additionally, the biological evaluation should be re-evaluated if changes to any of the following occur:
- processing: sterilisation, cleaning, manufacturing procedure
- material source (new vendor)
- material specification
- formulation
- storage conditions
- environment of clinical use
All of the above changes may affect the biocompatibility of the device. It is therefore necessary to assess the risk associated with each change and determine if any additional data is required to confirm biological safety.
It is a requirement that the “Biological evaluation should planned, carried out and documented by knowledgeable and experienced professionals”. Using our in-house toxicologist, Test labs offer a biological evaluation report (BER) which will identify the tests needed for your medical device, as well as sourcing available information on your product. After constructing the BEP and performing the required tests and sourcing the biocompatibility information, Test labs offer a biological evaluation Report (BER) with the complete set of justifications and results on your product.
