Best Practices for the State of the Art Evaluation
Based on Current European Union Regulatory Requirements and Guidance
By Priscilla S. Monarca, M.P.H.
Originally published May 5, 2023
What is the state of the art evaluation?
The state of the art evaluation is a necessary component of Clinical Literature Evaluations (CLEs) based on the European Union (EU) Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and current regulatory guidance. A state of the art analysis includes information regarding current and generally accepted therapeutic/diagnostic options that are considered good practice (state of the art) for the intended use and indications of the device under evaluation. The state of the art analysis includes information that allows a manufacturer and Notified Body to evaluate the device(s) under evaluation, including the acceptability of the benefits and risks of the subject device(s) in the context of what is state of the art.
What information is included in the state of the art evaluation?
The state of the art evaluation includes information for the device(s) under evaluation pertaining to the clinical background (medical conditions or indications); alternative therapeutic/diagnostic options; benefits and risks of the subject device type and alternative options; similar devices; and a state of the art conclusion based on information included in the evaluation. The goal of the state of the art evaluation is to determine best practices in the medical field under which the subject device(s) are indicated/intended for use, which means information in the state of the art analysis will not contain information solely for the subject device(s). Information pertaining to “similar devices” with the same/similar indications/intended uses will be included, as well as alternative diagnostic/therapeutic options.
It is important that the methods used to obtain sources for the state of the art evaluation accurately identify the necessary components discussed above. These methods include the use of appropriate literature databases and corresponding search strategies to identify relevant clinical literature, as well as the performance of environmental scans to identify relevant professional societies that provide updated guidelines in the applicable field. When topics yield a large amount of data, it may be appropriate to limit the type of literature (for example, systematic reviews, meta-analyses, guidelines, and general reviews); however, this is project-specific and requires an experienced literature reviewer to apply the appropriate methods to each individual project. When such limitations are applied, article types are selected through filters or key words used in the search strategies in the literature databases.
The selection and pairing of appropriate terms for the clinical literature search strategies are crucial for the successful identification of the different topics that are required for the state of the art evaluation. Generally, individual search strategies should be created for the different components of the state of the art evaluation. For example, individual search strategies may be focused on the clinical background, intended use/indications, alternatives, and similar devices. However, some of these topics may be grouped into one search strategy depending on the device and if there is limited information; conversely, some topics (such as intended use/indications or similar devices) may be divided into subgroups and subsequently, multiple search strategies. The latter is commonly observed when there is a large quantity of information for that topic, such as groups of devices or multiple similar devices within one CER.
Outside of clinical literature, professional society guidelines also are important to assess best practices in the relevant medical field(s) for the device(s) under evaluation. The environmental scan should be thorough in determining relevant professional society websites and subsequent guidelines. These guidelines provide further context on current practices in the field, and cover potential information gaps on clinical background and alternatives in the relevant field.
Once potential articles are identified through the literature database searches, knowledgeable reviewers must read the abstracts to determine which publications are appropriate for inclusion. Environmental scans for guidelines may be performed simultaneously. In reviewing the included sources, relevant medical information for the subject device (such as the medical condition(s)) must be described. Additionally, alternative therapeutic/diagnostic options with comparable intended uses/indications to the subject device type must be identified and summarized, incorporated into a summary of the subject device type; this summary will also include an evaluation of the benefits and risks of both the subject device type and the alternative options.
The qualitative summary should be cohesive, and quantitative assessments should be used when possible due to the increased emphasis the EU MDR places on quantitative data. The synthesis of this information contributes to the Notified Body’s evaluation of the device(s) under evaluation in the context of what is state of the art. Therefore, the interpretation and synthesis of the included literature and guidelines are just as crucial as the identification of the relevant sources.
Nerac has worked with many clients to remediate state of the art analyses after Notified Body audit findings. Common findings have been related to inadequate search protocol and/or search documentation, inadequate coverage of diagnostic or therapeutic alternatives, and inadequate evaluation of similar or benchmark devices to determine appropriate acceptance criteria.
Future editions of the Nerac Strategist will take a more in-depth look at similar devices in state of the art evaluations and using state of the art evaluations to develop your Clinical Evaluation Plan (CEP).
How Can Nerac Help?
Nerac’s Medical Device team has been assisting manufacturers with the state of the art requirement for several years, now with an updated and refined approach per the MEDDEV 2.7/1 Revision 4 guidance. Nerac’s Medical Device team creates a separate search strategy to obtain relevant clinical literature for the state of the art evaluation, which is supplemented by additional searches for applicable standards, guidance documents, clinical practice guidelines and consensus statements. Nerac’s team works collaboratively with each manufacturer’s team to determine the most appropriate approach for each device.
Nerac would welcome the opportunity to discuss state of the art with you and your team! Contact us here or call us at 860-872-7000 to learn more!