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Writing the State for the Art of medical devices according to the EU Medical Devices Regulation

Level:
Foundation
Area:
Medical Devices
Code:
MDF9
Duration:
03:30:00
Workshop profile:
This course is intended for medical writers with little experience in regulatory writing. We will assume that participants have basic knowledge of the directives and regulations governing medical devices, such as the MDD and MDR. (Reading about these regulations will be part of the pre-workshop assignment.)
Objective:
The State of the Art has become the strategic kick-off of any medical device evaluation. It includes information about the medical background, clinical conditions, and alternative therapies related to a medical device. In addition, the State of the Art section needs to identify benchmark devices, which are the foundation to define parameters for safety and performance, the risk-benefit profile, and respective acceptance criteria. Separate systematic literature searches are required to identify relevant background information and benchmark devices. Although the term “State of the Art” is mentioned several time in the EU Medical Devices Regulation 2017/745, and Notified Bodies pay special attention to this issue, there is a lack of clear definitions. 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 writer, 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 regular updates 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.
Content:
- Regulatory framework: EU MDR 2017/745 requirements and definitions - Content and structure of the State of the Art - Systematic literature searches for the State of the Art - Benchmark devices and benchmark parameters for safety and performance - How to compare the State of the Art information to the subject device - Review cycles and updates