The SSCP is a publicly available document summarizing safety and performance data on a medical device. It is intended to provide valuable information to healthcare professionals and patients. As outlined in Article 32 of the Medical Device Regulation (MDR 2017/745), manufacturers of Class III and implantable devices are required to submit an SSCP to the Notified Body (NB), as part of the documentation for conformity assessment.
In this blog post, we will explore the SSCP requirements, content, how to write the patient-specific section, readability assessment, and the validation process.
Requirements of the SSCP
The primary purpose of the SSCP is to provide clear, accurate and up-to-date information about the safety and clinical performance of a medical device.
The SSCP must be available in English and in the languages of the Member States where the device will be marketed. The language requirements follow those of the Instructions for Use (IFU), meaning that in Member States requiring patient information in specific languages, the patient section of the SSCP should be in the same language as the patients’ sections of the IFU.
Each SSCP is assigned a unique identifier and is made publicly available via the European Database on Medical Devices (EUDAMED). It must be regularly updated alongside the post-market clinical follow-up (PMCF) report and the Periodic Safety Update Report (PSUR) to reflect safety or performance data.
Content of the SSCP
The SSCP consists of two sections: one for healthcare professionals and one for patients, each clearly labelled and tailored to its respective audience.
Guidance on SSCP content is provided in the Medical Device Coordination Group (MDCG) 2019-9 Rev.1, with a template available in MDCG 2022-9 Rev.1.
The key input documents for preparing the SSCP include risk management documentation, Clinical Evaluation reports, clinical investigation reports, PMS and PMCF reports.
The sections of the SCCP for healthcare professionals and patients both contain the following elements:
- Device identification and general information: identification of the device, including name, class, basic UDI-DI, CE certification year; identification of the manufacturer, including name, address, single registration number; identification of the NB including name and single identification number.
- Intended use of the device: intended purpose of the device, indications, target population, contraindications.
- Device description: description of the device, accessories, design characteristics, operating principles, mode of action, previous generations, variants, and modifications.
- Risks and warnings: residual risks and undesirable side-effects (quantified where possible), warnings and precautions. Data sources must be specified (e.g., clinical studies with the device or literature reviews)
- For the patient section: residual risks and side effects should be explained in lay language, including how risks are managed, and what actions to take if side effects occur.
- Summary of clinical evaluation and post-market clinical follow-up: all clinical data (favorable or not) including summary of all clinical investigations, systematic literature review on the device, data from the Post-Market Clinical Follow-up (PMCF) report or Periodic Safety Update Report (PSUR), data from registries, planned or ongoing PMCF studies (summary of the PMCF plan). An overall summary of clinical performance and safety should be provided, including clinical benefits of the device, benefit-risk assessment, and acceptability of benefit-risk ratio.
- When claiming equivalence: identification of equivalent device, including name, Basic UDI-DI, manufacturer, and whether the SSCP is available in EUDAMED. If not, clinical data on the equivalent device must be summarized with sources mentioned (e.g., literature review, clinical investigation on equivalent device).
- For the patient section: clinical evidence for the CE marking should be presented, with short lay-summaries of clinical investigations, benefit-risk assessments for each indication, planned or ongoing PMCF studies wither their goals.
- Possible diagnostic or therapeutic alternatives: description of how the device compares to diagnostic or therapeutic alternatives in terms of benefits and risks.
- For the patient section: recommendation to discuss diagnostic or therapeutic alternatives with a healthcare professional.
- Suggested profile and training for users: description of the experience, education, training of the users, including mandatory trainings to use the device.
- For patient users: training requirements should be specified in the patient section.
The SSCP for healthcare professionals also includes:
- Reference to harmonized standards and common specifications: list of all applicable standards and common specifications.
- Revision history: includes SSCP revision number, date, description of changes, language of the SSCP that was validated by the NB.
How to write the patient part of the SSCP
A unique aspect of the SSCP is the patient section, which must be written in plain language, without medical jargon, to ensure accessibility. Patients must receive clear and concise information about the device, including its function, proper usage, and expected outcomes without being overwhelmed by excessive details. Risks and side effects associated with the device should also be explained appropriately.
Medical terms should be explained, and abbreviations or acronyms should be minimized. The use of active voice instead of passive voice is also recommended for clarity. The text should be understandable for a 6th to 8th grade level (approximately 11-14 years old).
Additional recommendations for writing to a lay audience include:
- The use of bullet-points, headers, and short paragraphs in a structured layout to improve readability.
- Incorporating diagrams, charts or illustrations to clarify complex concepts.
- Avoiding unnecessary or complex words.
- Consistency with the use of terms throughout the document and providing definitions.
Guidance on writing for lay audiences is available in the document Summaries of Clinical Trial Results for Laypersons, which, although not specific to the SSCP, provides useful principles.
Readability assessment
Poor readability can hinder the SSCP’s effectiveness, leading to confusion or misinformation. Readability tests, available in multiple languages, assess factors such as sentence length, passive voice usage, and paragraph structure. However, readability scores alone do not guarantee clarity.
One commonly used test for the English language is the Flesch Reading Ease test, which rates readability on a scale from 1 to 100. A score of 60 to 90 corresponds to a 6th to 8th grade reading level, with higher scores indicating easier readability.
The Flesch Reading Ease test has been adapted for languages, such as French, German, Dutch, and Spanish and can help scoring readability when the SSCP is written for a Member State using these languages.
Manufacturers may also conduct readability testing with laypersons to ensure comprehension.
Validation of the SSCP
The SSCP must be validated by a NB, which approves a single language version of the SSCP (also referred to as the “Master” SSCP). The manufacturer must indicate in the document history which language version has been validated.
Regular updates are required, with each revision subject to NB validation. The SSCP must align with the PSUR – whenever the PSUR includes new safety information, the SSCP must be submitted for validation alongside it.
Once validated, the NB uploads the SSCP to EUDAMED for public access, along with the certificate of conformity. For non-English SSCP versions, manufacturers must provide an English translation to the NB, which is uploaded to EUDAMED without further validation.
The SSCP is a critical document that provides updated information about the safety and performance of a device to the public. Particular care should be taken to ensure its readability and conciseness. Reach out to Lorentis if you need any support.
Are you interested in medical device documentation? Read our latest blog posts on literature reviews and clinical evaluations.
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