If It Wasn’t Documented, It Didn’t Happen … ?

The Biological Evaluation Plan (BEP) describes the strategy for investigating and ensuring the medical risk or biocompatibility of the medical device. The plan should describe and justify the biocompatibility assessment procedure in detail. All available information on the intended use of the device, the device configuration and design, the materials used in the device and in the manufacturing process, the production conditions and, if applicable, existing preclinical and clinical data should be taken into account.

The biological evaluation plan will then identify the gaps in the biocompatibility assessment and, based on ISO 10993-1, provide an expert recommendation on how to close these gaps most efficiently.

The development of a qualified biological assessment plan is expected by the authorizing institutions and authorities. In accordance with ISO 10993-1, it is also expected that all steps of the biocompatibility test in planning, execution, evaluation and documentation are carried out by experts.

Finally, all data are compiled and evaluated by experts and summarized in the Biological Evaluation Report (BER). At the end, a qualified statement on biocompatibility and, if applicable, a biocompatibility certificate should be available as an important part of the authorization documents.