The State of the Art section is not a new requirement under the EU MDR 2017/745.
However, the provisions for this section have been enforced, and it has become the fundament of the Clinical Evaluation Report.
The State of the Art section needs to identify benchmark devices besides information about the medical background, clinical conditions, and alternative therapies related to a medical device. Data about these benchmark devices are relevant to define safety and performance parameters and acceptance criteria. These criteria compare the subject medical device to the current State of the Art.
This requires a thoroughly structured systematic literature search and a deep understanding of the medical conditions related to the subject device.
Understanding the relevant parts of a State of the Art section and knowing where to start can be challenging.
Also, as a medical device professional, you may face devices with little background information for which the literature search can become challenging.
This workshop will give you profound insights into the State of the art's regulatory requirements, best practice recommendations on how to structure your search, and how to identify your benchmark devices and parameters.