Last Updated on January 20, 2024 by BIOMEDRIC
According to ISO 10993-1 (2018): “The biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971:2007 (the standard has been revised by ISO 14971:2019). This risk management process involves identification of biological hazards, estimation of the associated biological risks, and determination of their acceptability. The biological evaluation shall be planned, carried out, and documented by knowledgeable and experienced professionals.”. Thus, the biological evaluation plan is a crucial first step in the biocompatibility assessment of a medical device; the plan details the overall strategy to prove the biocompatibility of medical devices within a risk management process. In accordance with ISO 10993-1 (2018), as well as the trends of the European authorities (EU MDR 2017/745) and the FDA, physical and/or chemical characterization shall precede any biological test in the biological evaluation plan.
According to ISO 10993-1 (2018), the biological evaluation plan should include as a minimum:
— arrangements for gathering applicable information from the published literature;
— arrangements for conducting the evaluation;
— arrangements for review and approval of the plan;
— arrangements for review of the final conclusions of the evaluation and the approval of any additional testing required;
— arrangements for the final review and approval of the outcomes of the biological risk assessment.
An Overview of Major Parts of Biological Evaluation Plan for Medical Devices
- Identification of relevant biocompatibility standards and, if applicable, biocompatibility standards specific to the medical device category (e.g. ISO 18562 (2017)-1, 2, 3, 4 for respiratory medical devices);
- Identification of potential risks from a biocompatibility perspective considering material components, manufacturing process, description, and clinical use of the medical device;
- Identification of category of the medical device considering nature and duration of contact with the human body;
- Identification of the extent of material characterization required considering the invasiveness and duration of clinical exposure in the intended use (ISO 10993-1:2018);
- Analysis of material characterization data obtained according to ISO 10993-18 (2020) in the toxicological risk assessment report prepared by a competent expert;
- Identification and justification of whether additional biological tests are required;
- Holistic analysis of whole results, including additional biological tests judged to be necessary.
It should be pointed out that the biological evaluation plan has to be re-evaluated in case of evidence regarding the adverse effects of the medical device on human health revealed by post-market surveillance studies, as well as in case of a change in material characteristics, design, and intended use of the medical device.
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