SSCP User test Readability of the Summary of Safety and Clinical Performance
The objective of the Medical Device Regulation (MDR) on SSCP’s is to enhance transparency and provide adequate access to information. 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 the medical device.
The SSCP will therefore be an important source of information for intended users- both patients and healthcare professionals.
The accessibility of the information of the SSCP can be valided by RA professionals, expert patientgroups or notified body.
SSCP User test in Girls younger than 14 years who have been diagnosed with epilepsy.
Readability of the patient-specific SSCP (Summary of Safety and Clinical Performance)
The objective of the Medical Device Regulation (MDR) on SSCP’s is to enhance transparency and provide adequate access to information. 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 the medical device.
The SSCP will therefore be an important source of information for intended users- both patients and healthcare professionals.
The accessibility of the information of the SSCP can be valided by RA professionals, expert patientgroups or notified body.
Key principles in ‘Summaries of Clinical Trial Results for Laypersons’ :
– short, succinct sentences conveying factual and objective information; the data should not be skewed or include promotional language
– simple language, avoiding acronyms, medical/technical terms and multisyllabic words
– visuals and illustrations to convey information where appropriate
– numerical data presented in a way that is understandable to the target audience
– eye-friendly formatting, including minimum size 12 font and plenty of white space
Comprehension include understanding of key messages and information points in the SSCP.
LINK: The European Union Medical Device Regulation – Regulation (EU) 2017/745 (EU MDR)
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Regulatory environment
The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed)1 .
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 the medical device. The SSCP will be an important source of information for intended users – both healthcare professionals and if relevant for patients. It is one of several means intended to fulfil the objectives of the Medical Device Regulation (MDR) to enhance transparency and provide adequate access to information.
“(43) Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.’’