Reprocessing of single-use devices
This webpage provides information for stakeholders about the reprocessing of single-use devices (SUDs).
What is an SUD?
An SUD is a device used on one individual during a single procedure.
What requirements apply to SUDs?
Article 17 of the Medical Devices Regulation (MDR) outlines provisions allowing for the reprocessing of SUDs where permitted by Member States at a national level.
The national position in Ireland is set out in S.I. 261 or 2021. This S.I. allows for the reprocessing of SUDs only in line with Article 17(2) of the MDR.
Requirements for reprocessors
If you reprocess SUDs in Ireland, you will act as the legal manufacturer of the SUDs.
If you reprocess SUDs in Ireland, you must fulfil applicable MDR requirements. This includes, but is not limited to, requirements for conformity assessment, CE marking, traceability and labelling.
Requirements for health institutions
Manufacturers must assign the intended use of their devices, including whether it is single-use or reusable.
Health institutions should only reprocess SUDs (sterile or non-sterile);
when specified by the manufacturer, and
where the original equipment manufacturer (OEM) supplies reprocessing instructions with the SUD.
Reprocessing instructions should include details on the processes to allow reuse such as cleaning, disinfection, packaging as well as any restriction on the number of reuses.
If you conduct reprocessing activities outside of the OEMs instructions you will be acting as a reprocessor in line with article 17 of the MDR.
If you conduct such activities, you will be acting as the legal manufacturer in line with the MDR.