The Summary of Safety and Clinical Performance (SSCP) is the public summary of key safety and performance information for certain high-risk medical devices. It is prepared for implantable devices and Class III devices, unless they are custom-made or investigational devices. The Notified Body validates the report before it is made publicly available via EUDAMED.
Target Audience and Content of the Summary of Safety and Clinical Performance
The report is not exclusively aimed at professionals. The information must be presented in an understandable manner for users and, where applicable, patients, without oversimplifying the technical and clinical basis. The MDR requires information on product identification, intended purpose, risks and warnings, as well as a summary of the clinical evaluation and post-market clinical follow-up. Depending on the user group, the language and emphasis of the content may vary.
The source of the Summary of Safety and Clinical Performance is the technical documentation. Therefore, the presentation must be consistent with the intended purpose, product description, clinical benefit, remaining risks, and alternatives. A report describing a different product variant than the clinical evaluation creates unreliable public information for users. The Notified Body’s validation specifically focuses on whether the provided text meets legal requirements and adequately reflects the underlying documentation.
Update and Public Availability
The Summary of Safety and Clinical Performance is not drafted once and then archived. Changes arising from the clinical evaluation, the post-market clinical follow-up report, or periodic safety update reports may necessitate a revision. Manufacturers must incorporate the status of the Summary of Safety and Clinical Performance into their document control and clearly record which version has been validated by the Notified Body. Public comprehensibility is not an exception to this version control.
Publication is carried out via EUDAMED. The requirement to provide the report in a readable and not easily alterable format ensures access to a reliable version. A publicly available Summary of Safety and Clinical Performance is not an advertising brochure. It describes the evidence-based state of knowledge in a form that reveals the product’s limitations, risks, and intended use.
Distinction from Study Reports and Patient Information
The existing entry “clinical-study-report” refers to the detailed report of a clinical study. The “clinical-evaluation-report” documents the scientific assessment of clinical data for a product. The Summary of Safety and Clinical Performance is neither the complete study report nor the internal clinical evaluation report, but a publicly designated, validated summary of relevant findings.
The instructions for use and the implant card also remain independent documents. The instructions for use guide safe use; the implant card conveys patient-related information for an implanted product. The Summary of Safety and Clinical Performance replaces neither and contains no individual treatment recommendation. Its function is to provide transparent information on the safety and performance aspects of a product, not to offer advice for specific therapeutic decisions.
A useful Summary of Safety and Clinical Performance also highlights the limits of existing knowledge. If clinical follow-up is ongoing or data are primarily available for a narrowly defined population, the summary must not suggest greater safety or performance. The combination of understandable language and precise risk representation is particularly challenging because the text should provide appropriate guidance to both professional users and laypersons.
Relevance for clinical trials
Clinical investigations often provide essential building blocks for the clinical evaluation of an implantable device or a Class III device. Study data must therefore be collected and evaluated in such a way that benefits, risks, adverse events, and the patient group studied can later be comprehensibly transferred into the public summary. An imprecise description of the product version or indication not only complicates the study report but also the subsequent consistent communication in the Summary of Safety and Clinical Performance.
Full-service CROs like Mediconomics provide support through medical writing for clinical study reports, data audits for safety and performance endpoints, literature searches for clinical evaluation, and document version tracking. This enables them to structure the information base from which manufacturers derive the validation-required Summary of Safety and Clinical Performance and its updates.
The summary must also precisely identify the product so that readers can associate the presented evidence with the correct model and intended purpose. For variant families, a blanket statement without this reference is particularly misleading.
Frequently Asked Questions (FAQ)
For which products is a Summary of Safety and Clinical Performance required?
It is required for implantable devices and Class III devices, with the exception of custom-made and investigational devices.
Who validates the Summary of Safety and Clinical Performance before publication?
The Notified Body validates it. Only the validated version is made publicly available in the designated system.
Can a patient use the Summary of Safety and Clinical Performance as instructions for use?
No. The report provides general, public safety and performance information. Instructions for use and individual medical decisions remain reserved for other documents and healthcare professionals.
Regulatory References
- Regulation (EU) 2017/745, Article 32 – specifies the preparation, validation, and public availability of the Summary of Safety and Clinical Performance.
- Regulation (EU) 2017/745, Annex I – forms the basis for the product’s safety and performance information.
- Regulation (EU) 2017/745, Annex XIV – regulates clinical evaluation and post-market clinical follow-up.
- MDCG 2019-9 Rev.1, Summary of safety and clinical performance – provides guidance to manufacturers and Notified Bodies on the report.
