FDAnews Device Daily Bulletin

HPRA Issues Guidance on Device Standalone Software

July 6, 2017

Ireland’s Health Products Regulatory Authority released new guidance on medical device standalone software.

The software is considered an active medical device, the guide notes, so it must be assigned one of the HPRA’s four risk classifications, I, IIa, IIb or III. The classification determines which conformity assessment procedure the software must undergo. 

The process for Class I standalone software, for example, does not require the input of a notified body; all such software may bear the CE mark if the sponsor complies with the European Commission’s declaration of conformity procedure. All other standalone software is eligible for the CE mark if it follows the relevant requirements for its classification, according to the guide.

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