Reprocessing

Manufacturers of reusable devices have to provide validated reprocessing instructions, and changes to those instructions can affect a 510(k) or the technical documentation. In the EU, reprocessing of single-use devices is a separate topic governed by Article 17 of the MDR and national rules.

‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;

EU MDR, Article 2(39)

Validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization.

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

The MDR definition covers any process that allows safe reuse of a used device and includes testing and restoring its technical and functional safety. The FDA 510(k) guidance describes validated processes that make a used or contaminated device fit for a subsequent single use, with a focus on cleaning and microbial inactivation.