Biological Evaluation According to EN ISO 10993

Biocompatibility support from analysis to strategy

Need help with your Biological Evaluation Plan (BEP)?

BioTop Medical guides you through every step of biological evaluation under EN ISO 10993—from BEP to final BER.

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A biological evaluation is required for demonstrating the biological safety (also called biocompatibility) of any medical device that comes into direct or indirect contact with the human body. At BioTop Medical, we support manufacturers by preparing a Biological Evaluation Plan (BEP) and delivering a Biological Evaluation Report (BER) that complies with EN ISO 10993-1. We offer guidance—from data gathering to, if required, testing recommendations—ensuring a complete and defensible assessment.

Biocompatibility: definition & regulatory relevance

Biocompatibility refers to the ability of a device material to perform its intended function without eliciting adverse biological responses. Under EN ISO 10993-1, it is not just about test results—it’s about justifying material safety within the full context of risk management and use.

Performing biological evaluation

Applying biological evaluation properly depends on understanding both your device and the applicable standards. BioTop Medical provides:

  • A structured BEP based on EN ISO 10993-1
  • Clear justifications for endpoint selection and testing
  • A final BER for inclusion in your Technical Documentation File

Determine the nature of body contact

Understanding the nature, duration, and frequency of body contact is the foundation of a compliant biological evaluation. The biocompatibility of the device is related to the tissues the device contacts and how long the contact is, from less than a minute to longer than thirty days. For example, a device that only briefly contacts intact skin will typically have less risks for biocompatibility than a device that gets into direct or indirect contact with the blood circulation.

Based on this categorization, we determine which biological endpoints are relevant and whether existing data is sufficient.

Obtain physical and chemical information

A critical requirement under EN ISO 10993-1 is to obtain physical and chemical information about each component and material. We assist in:

  • Identifying all device materials
  • Understanding the impact of the manufacturing processes
  • Evaluating the source and quality of supplied materials

Risk assessment & selection of biological endpoints

Based on the medical device material information and contact categorization, we conduct a structured risk assessment in line with EN ISO 10993-1. This includes:

  • Identifying applicable biological endpoints
  • Identifying possible risks related to materials and the manufacturing process
  • Determining and justifying whether testing is needed or not

Testing strategy and biocompatibility assessment

Different than was previously thought; the list of biological endpoints found in the standard is not intended to be a testing checklist. Therefore, our strategy revolves around identifying gaps in the current knowledge and only recommending testing if the information cannot be gained another way. This is especially relevant when animal testing would be involved, as the need for this type of testing needs to be properly justified.

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    Services

    For direct contact call
    +31 (0)71 528 01 12

    Questions? Contact us
    info@biotopmedical.nl

    FAQ about Biological Evaluation

    Is it mandatory to perform a biological evaluation?

    Biological evaluation relates to the risks of exposure to the device materials on users and patients. Therefore, a biological evaluation for medical devices is mandatory if the device gets into direct or indirect contact with users and/or patients. Alternatively, devices that have neither direct nor indirect contact will not require a biological evaluation, because there is no risk of exposure to the device materials. These non-contacting medical devices are typically software or in-vitro diagnostic devices.

    Should all biological endpoints be addressed through testing?

    Not necessarily. Contrary to how the EN ISO 10993-1 standard was interpreted in the past, the endpoints are not intended to be a “checklist” for required testing. If the available information is sufficient to show that the risk for a specific endpoint is low, it can be argued that there is no need for further testing. Furthermore, EN ISO 10993-2 on animal welfare requirements states that animal testing needs to be justified and should not be performed if the information can be gathered another way.

    However, be aware that the US Food and Drug Administration historically tends to require more testing than Notified Bodies in the European Union, so it should be evaluated on a case-by-case basis.

    What is a BEP?

    The Biological Evaluation Plan (BEP) is the document in which you define the nature and duration of contact with the medical device and collect all the available information on the materials, manufacturing and other relevant data. Based on this information, you can evaluate the potential risks for biocompatibility and evaluate if the information is complete and if further testing of endpoints is required. This document is written within the scope of the device risk management process, so it important to make proper links to the risk management file.

    What is a BER?

    The Biological Evaluation Report (BER) is the document that is written after further testing of endpoints, or other relevant testing, is performed and in which it should be concluded that all risks for biocompatibility are addressed and reduced as far as possible.