The State of the Art section is not a new requirement under the EU MDR 2017/745. However, the requirements for this section have been enforced, and it became 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 are used to 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, especially when writing your first Clinical Evaluation Reports.
Also, as a medical device professional, you may face devices with little background information for which the literature search can become a challenge.
Finally, the State of the Art section is subject to predefined review cycles and will also be included in other documents, such as the Summary of Safety and Clinical Performance (SSCP).
This workshop will give you profound insights into the regulatory requirements for the State of the Art, best practice recommendations on how to structure your search, and how to identify your benchmark devices and parameters.