The legal requirements for the maintenance of medical devices are set out in Art. 71 of the Medical Devices Ordinance (MedDO, SR 812.213) and Art. 64 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219).
The «Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten» (GPI) is the guideline that describes the requirements according to Art. 71 para. 4 MedDO and Art. 64 para. 4 IvDO. Its application is mandatory for all hospitals and any deviations must be assessed accordingly, remedied or justified and documented if necessary. The implementation of the GPI in hospitals is reviewed by Swissmedic as part of administrative proceedings, including inspections.
GPI was prepared by Swissmedic in collaboration with the professional associations «Infrastruktur Hospital Schweiz» (IHS) and «Interessengemeinschaft für Wiederaufbereitung im Gesundheitswesen» (IG WiG).
Based on the input from the consultation in mid-2024, the GPI was restructured and certain topics were expanded for a better understanding. No significant changes were made to the content. Suggestions for improvement of a next version of the GPI are welcome.
The following checklist is based on GPI version 2 from 2025 and Swissmedic uses it when inspecting hospitals with regard to the maintenance of medical devices. It can be used by healthcare facilities to perform gap analyses with regard to GPI requirements and for internal audits, for example.
Maintenance of sterilization containers
The following document (available in German, French and Italian) provides details of the requirements for the maintenance of sterilization containers (in accordance with standard SN EN 868-8):
Heater cooler units
In 2017, the Federal Office of Public Health and Swissmedic issued guidelines for operating and monitoring heater-cooler devices/units in operating theatres on the basis of recommendations issued by the Swiss Mycobacterium chimaera expert task force.
Link to the information from the FOPH (in German):
New medical devices regulations
New medical devices regulations came into force on 26 May 2021. An information meeting was held (in French and German) on 2 September 2021 to explain the impact of the new regulations on the different players in the Swiss medical devices sector.
Information on the new medical devices regulations (French and German only):
One presentation dealt with healthcare institutions and the new requirements facing them, particularly as regards maintenance. This presentation is available on the Swissmedic website:
Presentation on requirements pertaining to healthcare institutions:
The following document (only available in German, French and Italian) provides further details on the legal requirements for professional users and third party maintenance of medical devices:
