Summary of Safety and Clinical Performance (SSCP)
Overview
The SSCP (Summary of Safety and Clinical Performance) is a publicly available document providing a comprehensive summary of device safety and clinical performance data accessible to healthcare professionals and, where relevant, patients. Required by MedDO Art. 35 for Class III devices and all implantable devices (excluding custom-made and investigational devices). Must be written in terms understandable to intended users and, where relevant, to patients.
Content Requirements (MedDO Art. 35)
- Device identification — name, model, intended purpose, UDI, CE status
- Intended purpose and indications — target patient population, indications, intended users
- Device description — materials, design principles, variants
- Risks and benefits — summary of clinical evaluation, serious risks, mitigations
- Residual risks and undesirable side effects — from clinical evaluation and PMS
- Patient profile — and contraindications
- Clinical evidence summary — types of data used
- Applicable legislation and standards
- Date of last update
- Access means — link or reference to the full SSCP
NB Validation
The NB validates the SSCP as part of conformity assessment for Class III and implantable devices, reviewing it for accuracy, completeness, and accessibility.
Swiss Language Requirements
The SSCP must be available in German, French, and Italian where the device is available to patients. For professional-use-only devices, fewer language versions may be required.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
The SSCP must be updated and revalidated by the NB whenever significant new safety or performance data becomes available, including post-market surveillance findings, serious incidents, or material changes to the device design or intended use. The update frequency should be defined in the manufacturer's post-market surveillance plan.