As outlined in ISO 10993-1, the biological evaluation of a medical device should be conducted within a risk management framework in accordance with ISO 14971 risk assessment methodologies. This process typically begins with a thorough assessment of the device, including its material composition, manufacturing processes, clinical use, intended anatomical location and exposure. Based on this data, potential biocompatibility risks should be identified. Each medical device presents unique risks depending on its materials and design, making it essential to avoid a one-size-fits-all approach to biological evaluation. Nonetheless, identifying and quantifying the constituents of a medical device is a crucial initial step in the process, as it plays a significant role in hazard identification.
Once these risks have been identified, the manufacturer should evaluate the existing information regarding those risks and identify any remaining knowledge gaps. Considering the potential biological impact, a plan should be developed to address these gaps, whether through biocompatibility testing or other evaluations that appropriately address the identified risks. This may include reviewing literature and other publicly available information, relying on consensus standards and clinical experience, as well as comparing with clinically established medical devices.
Given the complexity of evaluating the biological safety of medical devices, many potential pitfalls exist. One major issue is the lack of a well-structured Biological Evaluation Plan (BEP), which outlines the strategy for assessing the device’s safety according to ISO 10993-1. While ISO 10993-1 serves as a framework for planning a biological evaluation, there is no defined template for this document. Thus, a common pitfall is that the BEP is often underestimated and frequently fails to comprehensively address all aspects that need evaluation. This can lead to inconsistent and incomplete safety assessments, increasing the risk of safety issues being overlooked.
Another pitfall is testing raw materials instead of the final product. This oversight may overlook potential interactions that may occur during manufacturing. Furthermore, the impact of shelf life and aging on safety could be overlooked, which is particularly critical for devices that may degrade over time. Inadequate chemical characterization can also lead to missing harmful substances; therefore, thorough identification of extractables and/or leachables is vital, if appropriate.
In summary, numerous aspects need to be evaluated to ensure compliance with regulatory requirements and to conduct a thorough assessment of your device. Regardless of the development stage you are in with your product, if you need support to evaluate your current documentation or assistance with authoring, feel free to reach out to us via our Contact page.