Reprocessing refers to a process carried out on a used device in order to allow its safe reuse. It includes its cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.
At Test Labs, we offer testing services to ensure the reprocessing instructions outlined in your Instructions for Use (IFU) are fully validated. Validation of reprocessing follows the principles and guidelines described in BS EN ISO 17664-1 (critical and semi-critical MD) and BS EN ISO 17664-2 (non-critical MD).
The introduction of new requirements from the MDR for Class Ir Medical Devices has added an extra level of complexity for manufacturers to comply with the regulations. Self-certification will not the allowed for Class Ir, and therefore a Notified Body will be required to review the technical file. Specific attention will be given to the performance requirements of specific intended use, in this case reprocessing. Full validation of the reprocessing cycles included in the IFU needs to be included.