The HPRA, Ireland has provided updated information on its website concerning the national position on Article 17 of the Medical Device Regulation (EU) 2017/745 (MDR) and the reprocessing of single-use devices (SUDs).
What is a single-use device?
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.
About Article 17 of the MDR
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. It allows reprocessing of SUDs 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.
What are the implications for reprocessors?
Any natural or legal person reprocessing SUDs 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 the following:
- requirements regarding conformity assessment
- CE marking
- traceability
- labelling
What are the 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.
Source: HPRA website