Single-use device (SUD)

Single-use devices are not designed or validated for reprocessing. Reprocessing them is allowed in the EU only under Article 17 of the MDR and national law, and in the US the reprocessor takes on the obligations of a manufacturer.

‘single-use device’ means a device that is intended to be used on one individual during a single procedure;

EU MDR, Article 2(8)

‘single-use device’ means a device that is intended to be used during a single procedure;

IVDR, Article 2(9)

A device that is intended for one use or on a single patient during a single procedure.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology

The MDR limits a single-use device to one individual during a single procedure, while the IVDR refers only to a single procedure. The FDA 510(k) guidance speaks of one use or a single patient during a single procedure.