One of the core tenets of ISO 10993-1 is the risk-based approach for determining the safety of a medical device. In the new revision of the standard there is an emphasis on the qualifications of the people performing the evaluations and writing the assessments. These qualifications extend not only to formal schooling (a degree in biology, chemistry, toxicology, etc.), but to time and continuing education in the biological and toxicological risk-evaluation realm. Formal education provides a baseline for further development so the risk assessor understands topics such as metabolism, systems biology, material chemistry, and clinical science. Nothing beats tried and true on-the-job experience where theoretical and regulatory science converge. Not only must the risk assessor understand the ISO 10993 series of standards, but also other closely related standards (e.g., ISO 14971, ISO 7405, ASTM F2888) and international regulations (e.g., FDA use of ISO 10993-1 and EU MDR). Additionally, the assessor must have sufficient experience with submission feedback to understand current implementation practices and an awareness of current trends in reviewer interpretation of the relevant guidelines.
According to the new revision of 10993-1, published in 2025, the CV of the risk assessor must be submitted so that the regulator reviewing the document can have confidence that the risk evaluation has been performed thoroughly and accurately. The ideal assessor will have a strong background in a variety of device types and submission regions/types, will have been involved in standards development and, perhaps above all, will know how to craft the perfect storyline to help the reader thoroughly and directly understand the purpose, details, and conclusions of the assessment. The purpose of each assessment being written will be unique, and the chosen assessor and peer reviewer must understand the specifics of each requirement intimately. Authoring a change control for a material change requires a different set of skills than discussing the impact of a failed chromosomal aberration assay. Active involvement in national standards body working groups is key to understanding current and future thoughts and requirements across industry, regulators, and test labs.
Some of the documents previously submitted to regulatory agencies didn’t pass muster, and this was a part of the impetus for the increased requirements in the new 10993-1 revision. A question commonly asked in industry is How do I become knowledgeable enough to write risk assessments? The first step is to read all applicable standards and guidance documents. Another step is to attend educational courses, like the ones that Nelson Labs holds throughout the year, where hands-on discussion can happen most effectively. If you or someone at your company need relevant training to qualify as an expert assessor, there are an array of options. Members of the Nelson Labs Expert Advisory Services group are recognized across the industry for their involvement with standards and their depth of experience supporting submissions. They are able and ready to be your honest and unbiased partner in helping deliver safe and effective medical devices to patients.
If you need any support on a risk assessment or submission for your project, reach out to the Nelson Labs Expert Advisory Services team at [email protected]. Our experts will be happy to assist you.
