The Journal of mHealth Vol 1 Issue 2 (Apr 2014) | Page 55

UK's MHRA Issues Guidance on Stand-Alone Software and Apps UK’s MHRA Issues Guidance on Medical Device Stand-Alone Software and Apps The UK’s Medicines and Healthcare Products Regulatory Agency (MHPR) has recently issued new guidance covering the regulation of software and applications which qualify as stand-alone medical devices. This follows the issuance of similar guidance by the FDA at the end of last year. Manufacturers, software developers, academics, clinicians and organisations are all increasingly using software for both healthcare delivery and social care needs. The MHPR guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device), as opposed to software which is integrated into a medical device. The full guidance text is reproduced here. The following guidance is for healthcare and medical software developers who are unsure of the regulatory requirements for CE marking stand-alone software as a medical device. INTRODUCTION Many manufacturers, software developer, academics, clinicians and organisations are using software for both healthcare and social care needs. This guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this is seen to be part of the device, e.g. software that controls a CT scanner. KEY POINTS AND EXISTING GUIDANCE Stand-alone Software Software which has a medical purpose, which at the time of it being placed onto the market, is not incorporated into a medical device. Intended Purpose Regulation of medical devices is limited by the intended purpose as defined by the manufacturer. This will include claims given in promotional materials for the device, e.g. brochures and WebPages. Medical Purpose Software that has a medical purpose could be a medical device. A medical device is defined in the medical device Directive (MDD) as: “software… intended by the manufacturer to be used for human beings for the purpose of: » diagnosis, prevention, monitoring, treatment or alleviation of disease, » diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, » investigation, replacement or modification of the anatomy or of a physiological process, » control of conception….” The other directive where this guidance is applicable is the active implantable medical device directive. Continued on page 54 We want to hear from you The thoughts and ideas of our readers and subscribers are essential to us at The Journal of mHealth. We want to hear your opinions on the mHealth industry. Contact us at [email protected] The Journal of mHealth The Global Voice of mHealth 53 The Journal of mHealth