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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Healthcare Institution Reprocessing
Under MedDO Art. 17 para. 2, healthcare institutions may reprocess single-use devices for use in their own patients only if they: establish and maintain a validated reprocessing procedure; implement appropriate quality assurance and risk management; maintain records of all reprocessing activities; notify Swissmedic of their reprocessing practices. The institution assumes full responsibility for the reprocessed device's safety and performance. Reprocessed devices must not be distributed to other healthcare facilities or the public.