UL Japan Official site

Biological Evaluation Plan (BEP) - Key Points for Developing a Biological Evaluation Plan

UL Japan

【Due to high demand, it has become an on-demand seminar】 Medical devices that come into direct or indirect contact with patients are required by regulatory authorities in various countries to conduct biocompatibility evaluations in accordance with ISO 10993-1. With the revision of ISO 10993-1 in 2018, it has become necessary not only in Europe and the United States but also in Japan to establish a Biological Evaluation Plan (BEP) based on biocompatibility risks before conducting biocompatibility tests and to properly execute the plan. In this seminar, we will convey a systematic approach to biocompatibility evaluation, introduce the challenges and factors that influence biocompatibility assessment, and outline the basic structure of the Biological Evaluation Plan (BEP). Target Audience: - Personnel responsible for medical device regulatory affairs - Those considering conducting biocompatibility evaluations for medical devices - Individuals interested in the Biological Evaluation Plan (BEP) This on-demand seminar is a recorded version of the online seminar held in July.