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Summary of Safety and Clinical Performance (SSCP)

Overview​

The SSCP is a publicly available document summarising device safety and clinical performance. 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)​

  1. Device identification — name, model, intended purpose, UDI, CE status
  2. Intended purpose and indications — target patient population, indications, intended users
  3. Device description — materials, design principles, variants
  4. Risks and benefits — summary of clinical evaluation, serious risks, mitigations
  5. Residual risks and undesirable side effects — from clinical evaluation and PMS
  6. Patient profile — and contraindications
  7. Clinical evidence summary — types of data used
  8. Applicable legislation and standards
  9. Date of last update
  10. 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​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.