As of January 30, 2026, Swissmedic has updated its guidelines for the maintenance of medical devices, introducing Version 2.1 of the Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten (GPI).
What changed?
The updated guidelines clearly reflect the requirements set out in Art. 71 para. 2 MedDO and Art. 64 para. 2 IvDO. Details can be found in the document’s change history.
Who is affected?
Clinical, quality, and regulatory teams involved in the maintenance of medical devices in Switzerland should be aware of these updates.
Why is this important?
The updated guidelines aim to ensure the safe and effective maintenance of medical devices, which is crucial for patient safety and public health.
FAQ
- What is the purpose of the GPI guidelines?
The GPI guidelines provide a framework for the maintenance of medical devices in Switzerland, ensuring compliance with regulatory requirements and promoting patient safety. - How do the updated guidelines affect my organization?
The updated guidelines may require your organization to review and update its maintenance procedures to ensure compliance with the new requirements.
Conclusion
The updated GPI guidelines are an important development for the medical device industry in Switzerland. By understanding the changes and implications, clinical, quality, and regulatory teams can ensure compliance and promote patient safety.
Disclaimer
This article is for informational purposes only and should not be considered as legal advice. For full information about the Swissmedic announcement, see the link below.
Swissmedic Announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/maintenance.html