Biological Evaluation Plan for Medical Devices

What is a Biological Evaluation Plan?

A Biological Evaluation Plan (BEP) is an essential step in the medical device market approval process. This plan is aligned with the ISO 10993 series, the international series of standards for the biological evaluation of medical devices. The 10993 series outlines a systematic approach for evaluating the potential hazards and harms between a medical device and the human body.

This vital document summarizes the device description, material characterisation, manufacturing, sterilisation and packaging processes and clinical use as per the information provided by the manufacturer, and existing data when available, that can include previous studies, literature reviews, and historical data. It then proposes the required tests to assess the device's safety based on the standards' guidance

How TÜV SÜD can help you with Biological Evaluation Plan?

• Expertise: TÜV SÜD has a team of biocompatibility experts with extensive knowledge and experience in biological evaluation plans for medical devices. Our team members have relevant degrees, certifications, and hands-on experience in the field.
• Regulatory compliance: TÜV SÜD is familiar with all major medical device regulations and standards, and proposes biological evaluation plans which are compliant with the latest standards and requirements.
• Timeliness: We understand that time-to-market is critical for our customers, and we work diligently to ensure that all deliverables, including biological evaluation plans, are completed within the required timeframe. Our project management team ensures that all deadlines are met and that our clients receive high-quality deliverables on time.

What our Biological Evaluation Plan service includes

Biological Evaluation Plans are intended to meet the objectives outlined in ISO 10993-1:2025, clause 4 “General principles" and considers, if applicable, the FDA Guidance Document to the ISO 10993-1.

The deliverable summarises the list of biological effects to be evaluated, which depend on the type of body contact and its duration, as per ISO 10993-1:2025, clause 6.4, “Categorization of medical device and determination of scope of evaluation”. 

According to the device’s intended use and the information provided by the manufacturer, the analysis of the biological effects ends in a recommendation of a series of tests to perform to the device to ensure biological safety. These may include in vitro and in vivo testing, chemical characterisation, and toxicological assessments, according to the general ISO 17025 requirements. 

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