Swissmedic’s Focus Campaign: Key Outcomes on PMS Compliance

Swissmedic conducted a focus campaign to assess compliance with the post-market surveillance (PMS) requirements of the Medical Devices Ordinance (MedDO) for higher-risk legacy devices. The campaign’s goal was to ensure manufacturers are adequately monitoring their medical devices after-market launch to detect potential issues early.

Key Findings:

• • Sample and Scope: The campaign reviewed 30 legacy devices in risk classes IIa and higher, with 28 of these products from foreign manufacturers.
  • Non-Conformities: Non-conformities were identified in 20 out of 30 cases, totaling 85 non-conformities across various PMS requirements.
  • PMS Plan and Safety Reports:
    • 11 products lacked a compliant PMS plan.
    • 8 products had safety reports not prepared according to the PMS plan.
    • 9 products had incomplete or missing information in the safety report.

Conclusions:

• • The MedDO requirements for PMS have been in effect since May 26, 2021. The campaign revealed that not all manufacturers are fully implementing these requirements.
  • Swissmedic will follow up on the rectification of non-conformities and may impose additional measures to ensure compliance.
  • Manufacturers are urged to review and enhance their PMS processes and documentation to meet MedDO requirements, ensuring patient health and safety.

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Questions about this new Swissmedic’s Focus Campaign and PMS Compliance? Contact us.

Related Resources:

• • PMS Requirements – Compliance with EU MDR
  • An Approach to PMS and PMCF for SaMD Startups – MedEnvoy
  • Medical Device CE Marking Compliance