Biological evaluation plan (BEP)

WHAT is a biological evaluation plan?

A biological evaluation plan (BEP) is a critical part of assessing the safety of a medical device. It involves a detailed examination of various aspects such as the device's design & structure, its material composition, manufacturing process & potential contaminants, the intended use, existing test results, and clinical history.

The BEP ensures that the device undergoes sufficient testing, with parameters selected from the ISO 10993-1 standard, which provides guidelines for the biological evaluation of medical devices.

WHY is the BEP important?

• First, as a manufacturer, you will need to have a BEP during the regulatory approval process to demonstrate the safety of your product.

• Second, as the BEP gives a structured approach to the risk evaluation, dictating which tests should be done to ensure patient safety, it minimizes the chance of product launch delays due to additional testing requirements from the authorities during the submission process.

• Third, a well-developed BEP can reduce testing costs by minimizing the chance of performing unnecessary or ill-suited tests for your product.

WHEN do you need a BEP?

The BEP should be developed during the initial design phase of the medical device. At this stage, developers can identify potential biological risks associated with the device's intended use, materials, and components.

Eventually, the manufacturer will need a BEP during the regulatory approval process before getting the medical device to markets - it has an essential role in demonstrating compliance with safety standards. 

It should also be taken into consideration that if there are changes to the device’s design, materials, or manufacturing processes, a new BEP may be necessary to evaluate the impact these changes have on biological safety. In addition, continuous monitoring of the device’s performance and safety in the market may also require updates to the BEP. Also, a BEP should guide preclinical testing to ensure a thorough evaluation of the device's safety.

At Measurlabs, we can provide a comprehensive BEP for a range of medical devices, while also guiding manufacturers throughout the process. Do not hesitate to contact us if you are developing a new device, seeking regulatory approval, making changes to an existing product, conducting post-market surveillance, or performing preclinical testing. 

We are also happy to create an offer for biocompatibility testing according to the BEP, as well as a biological evaluation report (BER) to summarize the results of the biological evaluation.