MDR Article 17: Reprocessing of Single Use Devices
A ‘single-use device’ (SUD) is defined in the MDR as a device that is intended to be used on one individual during a single procedure.
The MDR (Article 17) includes specific provisions allowing for the reprocessing of SUDs only where permitted by Member States at a national level. The national position in Ireland is set out in the Medical Devices Regulations S.I. 261 of 2021 and allows reprocessing of SUD only in accordance with Article 17(2) of the MDR. As a result, any entity reprocessing SUDs in Ireland will be considered the legal manufacturer of the reprocessed device.
Implications for Reprocessors
Any natural or legal person reprocessing SUD in the Republic of Ireland will become the legal manufacturer and must fulfil the requirements and obligations set out in the MDR. This includes, but is not limited to, requirements regarding conformity assessment, CE marking, traceability and labelling.
Implications for Health Institutions
It is important to note that the intended use of a device, including whether it is single-use or reusable, is assigned by the manufacturer. Health institutions should only reprocess SUDs (sterile or non-sterile) when specified by the manufacturer and when they are accompanied by specific reprocessing instructions provided by the Original Equipment Manufacturer (OEM). Such reprocessing instructions should include information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging as well as any restriction on the number of reuses.
Any reprocessing activities conducted outside of the OEMs directions/ instructions is considered reprocessing in accordance with article 17. Any entities engaged in such reprocessing activities are considered to be the legal manufacturer for the purposes of the MDR.