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Swissmedic: New «Swiss Good Practice for the Maintenance of Medical Devices» («Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten»)

10 February 2025

Swissmedic: New «Swiss Good Practice for the Maintenance of Medical Devices» («Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten»)

Swissmedic has published version 2 of the «Swiss Good Practice for the Maintenance of Medical Devices» («Schwerizerische Gute Praxis für die Instandhaltung von Medizinprodukten», GPI, document link). Swissmedic has developed the revised version in collaboration with the professional associations «Infrastruktur Hospital Schweiz» (IHS) and «Interessengemeinschaft für Wiederaufbereitung im Gesundheitswesen» (IG WiG).

The substantive requirements remain unchanged. However, the structure of the GPI has been optimized, and certain topics have been expanded to enhance clarity and comprehension.

The GPI serves as a guideline for the legally compliant maintenance of medical devices in accordance with Art. 71 of the Medical Devices Ordinance (MedDO) and Art. 64 of the In Vitro Diagnostics Ordinance (IvDO). It is mandatory for all hospitals. Any deviations must be assessed, documented, and, if necessary, corrected or justified. Swissmedic monitors compliance with the GPI by means of inspections and administrative procedures.

In addition to the updated GPI, Swissmedic has also published a checklist for hospital inspections related to medical device maintenance (document link).

For more information, see here.

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