Reporting device safety issues for manufacturers, authorised reps, importers, and distributors

How can manufacturers or authorised representatives report to the HPRA?

Vigilance reports can be submitted to the HPRA by email to

The vigilance requirements are outlined in Chapter VII, Section 2 of the MDR and IVDR and the relevant reporting forms are available on the EU Commission website.

How can importers and distributors report to the HPRA?

If an importer or distributor in Ireland suspects that a device presents a serious risk, or is a falsified device, they must inform us at once by email at

Guidance for industry

Guidance published by the Medical Devices Coordination Group (MDCG) is available here.