State of the Art (SOTA) Part I: What is a State of the Art Evaluation?

You have been reviewing the 4th revision of the European Commission’s Guidelines on Medical Devices, "MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC" to make sure you are following all requirements to get (or keep) your medical device on the market in the European Union (EU). The term “state of the art” is mentioned 39 times throughout the document, but what exactly does the European Commission mean by it and what are you supposed to evaluate according to the guidelines?

We are glad you asked! In this two-part series, we will start by reviewing what state of the art really means in the EU’s medical device guidelines and what their objective is in using the phrase.

What is state of the art?

Although state of the art is commonly defined as the newest idea or newest feature, state of the art in relation to European Commission regulations for medical devices does not imply the most technologically advanced solution. First mentioned on page 9 of the MEDDEV 2.7/1 guidance document, state of the art in this context refers to the current state (or current knowledge) of comparable treatment options. Another way to think of it is by asking “what is currently and generally accepted as good practice?” Moreover, the "MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies" gives a definition of state of the art as:

‘state of the art’: IMDRF/GRRP WG/N47 provides the following definition: Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes, and patient management, based on the relevant consolidated findings of science, technology, and experience.

It is important to note that the state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the “generally acknowledged state of the art".

What is the objective of the state of the art literature summary?

The MDCG 2020-6 guidance mentioned above provides some more information on state of the art and similar devices:

"Evaluation of state of the art, including evaluation of clinical data from similar devices. Data from similar devices may be also important to establish whether the device under evaluation and similar devices belong to the group of devices considered as “well established technologies” (WET)...Data from similar devices may be used, for example, to demonstrate ubiquity of design, lack of novelty, known safety and performance profile of a generic group of devices, etc.

Similar devices are also now defined in the MDCG 2020-6:

‘similar device’: 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.

"MDCG 2020-5 Clinical Evaluation - Equivalence: A guide for manufacturers and notified bodies" also talks about the use of data from similar devices. The guidance states that:

"In cases where equivalence cannot be demonstrated under the MDR, the data from similar devices may be useful for a variety of other purposes, for example:

1. Ensuring that the risk management system is comprehensive by identifying relevant hazards and clinical risks.

2. Understanding the state of the art, the natural course of the disease, and alternative available treatment options.

3. Helping to define the scope of the clinical evaluation, by identifying any design features in similar devices that pose special performance or safety concerns.

4. Provide input for clinical investigation design or post-market clinical follow-up design, and the post-market surveillance system.

5. Identification of relevant and specified clinical outcome parameters for the intended clinical benefits, based on the published clinical data pertaining to the similar device(s).

6. To define minimum requirements for a quantified clinical benefit that is considered clinically relevant, and/or to identify acceptable occurrence rates of risks and adverse events."

The goal of the state of the art standard is to demonstrate the acceptability of the medical device based on current knowledge. The state of the art clinical evaluation needs to demonstrate the current knowledge of the medical field, the standard of care, as well as available treatment options of the medical field including the device under evaluation, similar devices, and alternative treatments.

The state of the art should summarize standards and clinical practice guidelines of the medical field. The literature review includes an overview of safety and performance, including advantages, benefits, disadvantages, risks, and limitations, of the device, similar devices, and medical alternatives for the intended target groups and medical indications.

Check out the next installment of this series State of the Art: Part II - Unpacking Clinical Literature Review Objectives where we provide a breakdown of the objectives of the clinical literature review, how it compares to the safety and performance assessment, and state of the art items to include or evaluate.

Looking for related content? Check out on demand RQM+ Live! #11: I don't have clinical data for my device. What are my options for fulfilling the sufficient clinical evidence requirements under EU MDR? 

Sources:
1) European Commission. Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 and 90/385. Last updated 22/06/2020. Accessed 22/06/2020. https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/
2) European Commission. MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies. Last updated 24/04/2020. Accessed 22/06/2020. https://ec.europa.eu/docsroom/documents/40904 
3) European Commission. MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies.  Last updated 24/04/2020. Accessed 22/06/2020.  https://ec.europa.eu/docsroom/documents/40903