HPRA’s Guide for Medical Device Distributors!
2018/02/14
The Irish Competent Authority for medical devices, the “Health Product Regulatory Authority” (HPRA), published a Guide for Distributors of Medical Devices. This document aims to specify the obligations for distributors as outlined in the Regulations (MDR and IVDR), along with supplementary guidance and frameworks that can be used by distributors to meet those obligations. In addition, it sets out the HPRA’s recommendations for good distribution practices. A distributor may have alternative methods for achieving compliance with the regulations and, if justified, these alternatives may be equally acceptable.
Regardless of the fact that the document is issued by the Irish Competent Authority, it is focused on the content of the new EU regulations and thus contains much useful information for distributors throughout the EU/EFTA, and also for manufacturers seeking more clarity on how the responsibilities are divided between themselves and their distributors.