The SSCP (Summary of Safety and Clinical Performance) document is a useful source of information on the safety and clinical performance of a medical device.
It is crucial to correctly fill out this document to ensure safer, more transparent use of medical devices, which is the main goal of the MDR, the new European Medical Device Regulation.
The SSCP must be filled out for each device and stored in the EUDAMED database, so that it can be easily found and accessed.
The SSCP document is unique because it is aimed at two very different target audiences, namely patients and healthcare professionals.
Naturally, these two audiences have polar opposite levels of knowledge, expertise and expectations. One is a category of users who only use medical devices when needed, while the other is a community of experts in the field who use the equipment every day for their work.
Those who prepare the SSCP document therefore face the challenge of conveying information intended for two very different audiences in a single text. Thus, the text must have the following characteristics:
- explanations of medical terms and acronyms;
- scientific validity.
Let’s consider each point in more detail.
Readability and formatting
Readability is a characteristic that the MDR considers extremely important, so much so that it reiterates it as a key requirement in several places.
Ensuring that a document is readable involves taking a number of steps to help make the text easily understandable to readers.
This can be achieved through both the document’s language and its graphic layout.
In terms of language, terminology must be adapted to suit the target audience. Simple, explanatory words must therefore be used when addressing patients, whereas more specialized and technical language is generally used when addressing healthcare professionals.
The other means of ensuring that a document is readable is formatting, i.e., the use of a number of devices that make the text more readable, such as:
- using clear fonts;
- setting the font size to 12 to 14;
- avoiding walls of text by including spaces between paragraphs;
- using bulleted lists;
The combination of these steps makes it easier to read an SSCP document. However, to ensure that the content is adequately understood, a second requirement is necessary: explanation of medical terms and acronyms.
Explanation of medical terms and acronyms
As noted above, the SSCP document is also aimed at an audience of non-specialists, i.e. people who only occasionally use medical devices, but must nonetheless be informed about risks associated with their use.
Simplifying language is the key to making information perfectly accessible even to laypeople. Specialized concepts and terms should not be used without including a clear and unambiguous explanation. Acronyms, which frequently appear in medical and scientific texts, should also be used sparingly and explained the first time they are used, so that the reader understands precisely what they refer to.
The last requirement that must be met by an SSCP document is scientific validity.
To guarantee maximum transparency, which is the goal stipulated by the MDR, the SSCP document must share data on clinical studies with medical device users before the manufacture and marketing of the device.
Total transparency is required when presenting these data, i.e. all available data must be provided, including any critical data. The goal of maximum health safety prescribed by the European Regulation can only be achieved through this rigorous approach.
At Way2Global we are very familiar with the characteristics above when translating SSCP documents. Thanks to our team of specialized translators and professionals who handle the multiple stages of the workflow, we guarantee a faithful translation that reflects the content of the original text, adapting it to the language and culture of the new audience and removing any potential barriers that could limit the accessibility of such important documents.