Summary of Safety and Clinical Performance
Public-facing summary required for high-risk and implantable devices under EU MDR.
Definition
Per MDR Article 32, manufacturers must produce an SSCP for implantable and Class III devices. The validated document is published on EUDAMED so patients and healthcare professionals can access key clinical evidence. Custom-made and investigational devices are exempt. The SSCP summarizes the device, intended purpose, clinical evaluation, residual risks, suggested user profile and possible alternatives, and must be understandable to the intended user and, where relevant, to patients. The notified body validates it, and MDCG 2019-9 gives guidance on content.What this means in practice
SSCPs are validated by the Notified Body and updated at least annually for implants and Class III. They must be written in plain language for the patient sections.Examples
- A manufacturer of a Class III cardiac stent drafts an SSCP detailing its clinical benefits, risks, and performance data, which is then submitted to their Notified Body for validation.
- Following a post-market clinical follow-up study, a manufacturer updates the SSCP for their implantable hip prosthesis to reflect new long-term performance data and any updated risk information.
- A healthcare professional reviews the SSCP on EUDAMED for a new spinal implant to understand its clinical evidence and compare it with other available devices.
- • manufacturers may underestimate the importance of plain language requirements for the patient-facing sections, leading to documents that are not easily understood by the target audience.
- •Insufficient detail in the clinical performance sections can lead to Notified Body queries and delays in validation.
- •Failing to establish a robust process for annual updates and re-validation, especially for devices with ongoing clinical data collection, is a common pitfall.
- •Not aligning the SSCP content precisely with the Clinical Evaluation Report (CER) and other technical documentation can result in inconsistencies and regulatory scrutiny.
- •Overlooking the need for translation into relevant EU languages for the patient and healthcare professional sections can impede timely publication.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/745 governing medical devices in the European Union.
European Database on Medical Devices.
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Latest in MedTech
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MDCG 2019-9 SSCP GuidanceTier 2 VerifiedMDCGhealth.ec.europa.eu
- 2European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
- 3IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.