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

• Expertise: TÜV SÜD has a team of biocompatibility experts with extensive knowledge and experience in developing 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 ensures that biological evaluation plans are compliant with the latest 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.

Our Biological Evaluation Plans are intended to meet the objectives outlined in ISO 10993-1, clause 4 “General principles applying to biological evaluation of medical devices" and considers, if applicable, the FDA Guidance Document to the ISO 10993-1.

The deliverable summarises the list of biological endpoints to be evaluated as per Table A.1, ISO 10993-1, based on the factors listed above as provided by the manufacturer. The analysis of the biological endpoints 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.