New Swiss Good Practice for the Maintenance of Medical Devices (GPI) for hospitals

The legal requirements for the maintenance of medical devices are regulated in:

  • Art. 71 of the Medical Devices Ordinance (MepV, SR 812.213) and
  • Art. 64 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDV, SR 812.219).
Swiss Good Practice for the Maintenance of Medical Devices (GPI)

The “Swiss Good Practice for the Maintenance of Medical Devices” (GPI) is a guideline that explains the requirements according to Art. 71 Para. 4 MepV and Art. 64 Para. 4 IvDV.

  • It is mandatory for all hospitals and any deviations must be assessed accordingly, remedied or justified if necessary and documented.
  • The implementation of the GPI in hospitals is checked by Swissmedic as part of administrative procedures including inspections.
AboutLink to document
The GPI was developed in cooperation with the professional associations of “Infrastructure Hospital Switzerland” (IHS), the “Interest Group for Reprocessing in the Health Care Sector” (IG WiG) and Swissmedic. 

Based on the feedback from the consultation in mid-2024, the GPI was restructured and certain topics were expanded upon for better understanding.

However, no significant changes were made to the content. Suggestions for improvements for a next version of the GPI are being accepted.
Swiss Good Practice for the Maintenance of Medical Devices (31.01.2025)
This checklist is based on the GPI version 2 from 2025 and is used by Swissmedic as part of its inspection activities in hospitals in the area of ​​medical device maintenance.

The checklist can be used by healthcare facilities to carry out gap analyses with regard to the requirements of the GPI and, for example, for internal audits.
IN615_00_005d_CL Checklist for the inspection of the maintenance of medical devices (30.01.2025)