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Creation of the Summary of Safety and Clinical Performance (SSCP) is a new requirement under the Medical Device Regulation 2017/745 (MDR) for implantable and class III devices. It is a publicly available and objective summary of the clinical evaluation, tailored to address the intended users and patients where required. If the SSCP concerns a device for which it is relevant to provide information to patients, applying principles of plain language and health literacy is key to adequately communicating complex medical information and ensuring the readability of the SSCP.

What is the purpose of the SSCP?

The main objectives of the SSCP are to enhance transparency and to provide adequate access to information. It obliges manufacturers of high-risk devices to communicate all relevant clinical information to the public openly. Uploading an SSCP to Eudamed is mandatory for all class III and implantable devices except for custom-made and investigational devices. Legacy devices, i.e. devices certified under the Directives 93/42/EEC or 90/385/EEC and placed on the market after the MDR’s date of application, are also excluded from the SSCP requirement. The SSCP contains an unbiased up-to-date overview of all favourable and unfavourable clinical data and other information about the safety and clinical performance of a medical device. A particular focus is placed on the communication of residual risks and undesirable side-effects, as well as an objective discussion of therapeutic/diagnostic alternatives. The SSCP specifically addresses the intended users and always contains a part for healthcare professionals. If relevant, a separate version should be written specifically for patients. This fosters the empowerment of patients in healthcare.

MDR Article 32 defines the requirements for the SSCP and specifies that it “shall be written in a way that is clear to the intended user, and, if relevant, to the patient”. The SSCP does, therefore, not only provide a summary of the clinical evaluation but has to be readily understandable by the intended readers. This is especially important for the patient version, which has to be suitable for people with a low to average literacy level and no medical knowledge. This represents a major challenge for medical device experts used to communicate in specialist medical and/or regulatory language.

Addressing patients – not as easy as it sounds

Writing an understandable summary of complex clinical information for patients is difficult. More than simplified terms and avoiding specialist language alone are insufficient; various special measures beyond vocabulary are required. Some principles and guidelines for writing an SSCP are provided in the MDCG 2019-9 guidance and the therein referenced document “Summaries of Clinical Trial Results for Laypersons”. Moreover, there is an overall increasing emphasis on easy and tailored communication. A newly issued standard (ISO 24495-1:2023) covers general principles for plain language, which ensure that a document will be understandable to the intended reader. But what exactly are these principles, and how are they implemented?

Principles to support health literacy

There are various aspects of plain language and other measures to increase the readability of the SSCP for patients. This in turn supports health literacy and enables patients to receive transparent information related to their health. The different principles can be broadly summarized as follows:

  1. Language and writing style:
    The use of simple, consistent language is important. All relevant medical terms need to be introduced and explained. The text should consist of short and simple sentences that build on each other.
  1. Structure and layout:
    Beyond language, the structure and formatting of a document are key for cohesiveness. The most important information needs to be presented first and easily findable. Structuring a text into paragraphs with adequate white space and using headlines and bullet points improves readability.
  1. Numeracy:
    It is difficult to communicate complex numerical concepts to patients who are not familiar with them. However, the adequate comprehension of risks is a key goal of the SSCP. Various aspects of numeracy help to explain relevant basic principles and communicate the key numbers in an understandable way.
  1. Visuals:
    Appropriate visuals and informational designs are useful to emphasize important information and avoid long text. Graphics can be especially helpful to visualize risks.
  1. Testing of readability:
    To ensure that the SSCP is understandable by the intended audience, its readability should be tested using specialized tools, or, ideally, on a small patient sample.

Applying different principles of plain language and health literacy for SSCP writing is crucial, especially in the patient version. As outlined above, measures go beyond replacing complicated terms with simpler vocabulary. In addition to better understandability for patients, these measures increase the readability of the healthcare professional version by avoiding complex regulatory language.

Ronja Weber, PhD
Medical Writer ISS AG

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