News Category: Regulatory news
The HPRA has provided updated information on its website with respect to the national position on Article 17 of the Medical Device Regulation and the reprocessing of single-use devices (SUDs).
The website update notes the recently published Statutory Instrument, SI 261/2021, and the decision to opt into Article 17(2) of the MDR 2017/745. 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, requirements regarding conformity assessment, CE marking, traceability, labelling etc.
More information is available on our website, including a link to the recently published statutory instrument.