Personal Health Literacy: Demystifying Readability Requirements for SSCPs Intended for Patients

Qserve CRO

Date: 26 September 2023

Time: 17:00-18:00 PM CEST | 11:00 AM – 12:00 PM EST | 8:00 – 9:00 AM PST

Location: Virtual

Language: English


While the Medical Device Regulation (MDR 2017/745) strives to improve patient safety concerning medical devices, there is a similar movement in medical practice to improve patient outcomes through Personal Health Literacy (PHL). Health literacy is defined as the ‘‘capacity to obtain, interpret, and understand basic health information and services and the competence to use such information and services to enhance health.” While patient–provider conversations drive patient education, patients also use published materials to gain a greater understanding of healthcare options.

The Summary of Safety and Clinical Performance (SSCP) required by Article 32 of the MDR is just one of the regulatory documents that may require patient related content that can benefit from research in PHL. This free webinar will provide an overview of current research in patient readability, guidelines for writing patient specific content, and an overview of available tools to assess readability.

Learning Objectives

  • Brief overview of current research in PHL
  • Guidelines for improving readability and comprehension of written text in patient education materials (SSCP, IFU, etc.)
  • Guidelines for improving visuals and illustrations to enhance comprehension of patient education materials (IFU, brochures, websites)

The free webinar closes with a Q&A, which is often a popular part of our webinars, so we encourage you to send in questions prior to the webinar, and we will cover as many as possible. Use the registration form to send in questions, use the Questions Tab during the webinar, or mail them beforehand to

[1] Friedman DB, Hoffman-Goetz L. A systematic review of readability and comprehension instruments used for print and webbased cancer information. Health Educ Behav. 2006;33:352–373
[1] Nielsen-Bohlman L, Panzer AM, Kindig DA. Health Literacy: A Prescription to End Confusion. Washington, DC: Institute of Medicine, National Academies Press; 2004.

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