Regulatory
Summary of Safety and Clinical Performance(SSCP)
In one line
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.
Why it matters
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.
Common pitfalls
- • 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.
Sources
- MDCG 2019-9 SSCP Guidance · MDCG
- European Commission - Medical Devices · European Commission
- IMDRF Documents · IMDRF