What is the state of the art evaluation and what information is included?
The state of the art evaluation is a necessary component of Clinical Literature Evaluations (CERs) 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 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 with the same/similar indications/intended uses; and a state of the art conclusion based on information included in the evaluation.
This is described in more detail in our previous article: Best Practices for the State of the Art Evaluation.
What are Similar Devices?
Similar devices are devices that have the same or similar intended purpose as the device(s) under evaluation. This emphasis is guided by the In Vitro Diagnostic Regulation (IVDR), MDR, and relevant regulatory guidance documents. The Medical Device Coordination Group (MDCG) 2020-6 defines similar devices as:
devices belonging to the same generic device group. The MDR defines this as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics
In the IVDR, it is stated that the investigator’s brochure (IB) should include the following existing clinical data:
— from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device and/or of equivalent or similar devices;
— other relevant clinical data available relating to the safety, scientific validity, clinical performance, clinical benefits to patients, design characteristics and intended purpose of similar devices, including details of their similarities and differences with the device in question.
Based on these definitions, the similar device(s) may be created by the same manufacturer as the device under evaluation or different manufacturers. This also distinguishes one of the differences between similar devices and equivalent devices, which has a different definition but is occasionally (and incorrectly) referenced interchangeably with similar devices. This is not the only misunderstanding regarding similar devices. Occasionally, similar devices are referred to as “competitor devices,” but it is important to note that such terminology (“competitor devices”) arises from a marketing standpoint and does not reflect terminology utilized in the current EU regulations or guidance.
There is the expectation to identify similar devices under the current EU regulations, however, information about similar devices does not replace subject device data or equivalency data (if applicable) for supporting clinical evidence. Furthermore, similar device data not only contributes to the state of the art evaluation, but also to post-market surveillance (PMS), pre-clinical data, and clinical data. The similar device data included in the state of the art analysis should be consist with manufacturers’ clinical data and risk management documentation for the subject device(s). Under current EU regulations and guidance, similar devices are an essential component of CERs for multiple content areas; thus, it is important to understand and appropriately apply for continued Conformitè Europëenne (CE) Marking.
Future editions of the Nerac Strategist will take a more in-depth look at using state of the art evaluations to develop your Clinical Evaluation Plan (CEP) for the EU MDR 2017/745, as well as state of the art evaluations and scientific validity for the EU IVDR 2017/746.
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!