The Importance of BEP and Report in Medical Devices

The Importance of Biological Evaluation Plan and Report in Medical Devices

Authors: Bartosz Gromadka¹, Łukasz Szymański¹, Damian Matak¹

¹ European Biomedical Institute, Józefów, Poland

Keywords: biocompatibility, ISO 10993, medical device, BEP, BER, BRA

Introduction

Medical devices play an essential role in healthcare and can have a significant impact on patient health and safety. To ensure the safety and effectiveness of medical devices, regulatory authorities worldwide require manufacturers to conduct a risk assessment and biological safety evaluation. This evaluation process involves the creation of a Biological Evaluation Plan (BEP) and the submission of a Biological Evaluation Report (BER), also known as a Biological Risk Assessment (BRA).

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