HPRA Publishes Draft Medical Device Distributor Guidance For Open Consultation

Author:Ms Alma Kelly and Ciara Farrell
Profession:Arthur Cox

On 4 April 2017, the Health Products Regulatory Authority ("HPRA") published for consultation a draft guide to distribution of medical devices and in vitro diagnostic medical devices ("Guide"). The draft Guide is intended to provide guidance to industry with a view to the adoption of the forthcoming EU Medical Device Regulations.

The draft Guide includes supplementary guidance to distributors by setting out the HPRA's recommendations for good distribution practice and other considerations for distributors of medical devices. One of the principal recommendations put forward in the draft Guide is to ensure that distributors have a quality system in place that covers, amongst others, the following:

Quality management; Personnel and staff training; Documentation and record keeping; Receipt, storage and supply; Returned...

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