The European Medical Device Regulation (MDR) 2017/745 requires that medical device manufacturers prepare summaries of safety and clinical performance (SSCPs) for implantable devices and class III devices. The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of a medical device. This information will become publicly available on the website of the EUDAMED database.
The SSCP shall be written in a way that is clear to the intended user, be it healthcare professional or patient. The text should be easy to understand and provide information at an appropriate depth to reflect the readers’ different levels of knowledge. This introduces a new challenge for med-tech staff because they have to prepare extensive and complex information for a different readership than they are used to.
In this webinar, you will learn how to tailor your SSCP to the two different target groups: healthcare professionals (Part A) and patients (Part B). This will include how to determine what information is relevant, how to reduce the length of the content and how to write it in a way that can be understood by the readers. We will discuss the structure and essential contents of both parts according to the MDCG 2020-19 Guideline, as well as where to find the respective information in the technical documentation and how to optimize their presentation in the SSCP.
You will learn hints and tips for improving readability that are easy to implement. Standard readability assessment tools will be presented. A combination of these two resources has been used by the pharmaceutical industry in the EU since user testing of package leaflets became mandatory in 2005. You will learn not only how to make your SSCPs MDR compliant but also how to make them target-oriented and informative for the intended users of your medical devices. Overall, this webinar will be a good balance between theoretical and practical elements that may help you to make your SSCP a good read!
Watch the Webinar On-Demand!