Any person who uses a medical device commercially or who uses it on a third party shall be obliged to take all the necessary measures for the maintenance of such device to ensure the continued performance and the safety of the medical device.
The Federal Council may:
specify the type of maintenance required for certain medical devices or certain classes of medical devices;
regulate the procedure for proving that the obligation of maintenance and the relative requirements have been fulfilled;
make the maintenance dependent upon the technical conditions.
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