State-of-the-art (SOTA) generally means the newest and most innovative technologies. In the Medical Devices industry, SOTA has had different meanings and interpretations primarily due to the ambiguousness of the definition mentioned in the different regulations. For instance, the European Union Medical Devices Regulations (EU MDR) 2017/745 does not give any proper definition to it. Further, guidance documents such as MDCG, ISO 14971: 2019, and others have their set of definitions on them.

The clearest definition of state-of-the-art until now is - the current knowledge or good practice acceptable in the medical devices industry. SOTA herein does not refer to newer technology, most frequently used, expensive, or less dangerous.

How is CER Related to State-of-the-art (SOTA)?

First of all, as a new requirement under the European Medical Device Regulation (EU MDR), all the manufacturers placing their devices in the European Union market are required to incorporate the SOTA report, which goes with the Clinical Evaluation Report (CER). The primary purpose of SOTA in the CER is to show the suitability of the device as per the current knowledge or standard practice.

How to Plan a SOTA Report?

A structured and streamlined approach should be taken into consideration while drawing up a SOTA report. Some of the key pointers to execute the report are:

  • Determine the search term and research questions.
  • Identify search databases.
  • Carry out a thorough literature search.
  • Understand the standards and guidance documents applicable to the SOTA report.
  • Review and analyze the results.
  • Draw up a SOTA report.

What Should be Done for an Effective SOTA Literature Search?

An effective literature search is important to identify appropriate methodology, design study, etc. For an effective literature search, one should keep an eye out for the classification terms that are used by the database and generate search terms based on the indication and target patient population. It is always advisable to use more than one database and not stick to one. In addition, use Boolean operators (AND, OR, NOT, parenthesis, asterisks, etc.), as this will help you in tailoring the information you require.

What Databases Should One Refer to for an Effective SOTA Literature Search?

Some of the useful databases for the SOTA literature search are:

What Information Should be Incorporated in the SOTA Report?

The data incorporation may vary in the SOTA report. However, the skeleton of the report should include the following:

  • Clinical background.
  • The medical field concerned with the device under evaluation.
  • Associated medical conditions.
  • Epidemiological data.
  • Historical aspects of the deduced medical field.
  • Alternative available technology available.
  • Clinical practice guidelines.
  • Similar devices.
  • Probable complications/hazards.
  • Safety and performance endpoints.

Drawing up a SOTA report can be a cumbersome Regulatory activity, given the various challenges posed in the pathway. Freyr has over a decade of experience in tackling medical writing challenges, and it can support you with all your specific requirements.

Book an appointment with us for any queries or concerns!