Single-use Devices
Overview
A single-use device is a device intended to be used on one individual during a single procedure. MedDO prohibits the reprocessing and reuse of single-use devices. Manufacturers must clearly indicate single-use status in labelling. The ISO 7000-1051 single-use symbol must be displayed on device packaging.
Prohibition on Reprocessing
MedDO Art. 17 prohibits reprocessing of single-use devices in Switzerland unless specific conditions are met. Healthcare institutions that reprocess single-use devices for use in their own patients must meet the requirements of MedDO Art. 17 para. 2 and notify Swissmedic.
Labelling Requirements
The manufacturer must: indicate single-use status prominently on the label; include the ISO 7000-1051 "do not reuse" symbol; provide information in the IFU explaining why reprocessing is not permitted (where this is not self-evident).
Official Sources
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