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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:
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