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The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device

May 7, 2020

Presenter: Dr Sophie Michel – Associate Biocompatibility Expert

In the evaluation of medical devices for biocompatibility, the assessment of patient safety should be made based on risk rather than on a check-box approach. In this aspect, we will see how to construct a Biological Evaluation Plan as per ISO 10993-1 (2018). The presentation will especially show how understanding patient contact and gathering information is the key in defining an adequate biocompatibility testing program.

*The presentation was recorded at our Open House Event in Leuven on 4 March. At that time there was no indication that the date for the entry into force of the MDR might be postponed.