Standalone software and applications
Standalone software including apps play an important role in the delivery of healthcare. For example, they may be used to control or monitor the performance of medical devices remotely, for patient management activities, or as an aid for treatment planning. Advances in mobile technology in recent years, such as smart phones and tablets, have seen a large increase in the use of mobile applications both within healthcare facilities, community settings and in patients’ homes.
Standalone software including apps may be considered a medical device in its own right when it is intended for a medical purpose that meets the definition of a medical device, as defined in S.I. No. 252 of 1994. Depending on the specific intended purpose, standalone software may qualify as an IVD medical device or an AIMD, in which case S.I. No. 304 of 2001 or S.I. No 253 of 1994 apply respectively.
Not all standalone software used in healthcare are medical devices. For example, apps for general health and wellbeing that record lifestyle habits such as smoking and exercise are generally not considered as medical devices.
It is essential that manufacturers of standalone software understand whether their product is a medical device or not. Only medical devices that are compliant with the relevant legislation can be placed on the Irish and European market.
It is important that users ensure that any standalone software including apps that they are using for a medical purpose are appropriately CE marked.
The HPRA has issued a number of publications relating to standalone software to provide guidance to manufacturers and users.