The MHRA has released guidance on the re-manufacturing of single-use medical devices.
A single-use device is used on an individual patient during a single procedure and then discarded. Single-use devices will have the following symbol on the device or packaging.
Re-manufacturing (of single-use devices) is different to reprocessing and is where a company obtains a CE mark for the re-manufacturing of single-use devices. Prior to placing on the market or putting into service, the device will be cleaned, disinfected and sterilised and be tested against the re-manufacturer’s specifications to ensure the single-use continues to operate safely and as intended.