On 14 June 2013, Phil Tregunno of the MHRA presented at our seminar on apps in pharmaceutical development on the subject of ‘Mobile Apps − A Regulatory Perspective’.
Phil first introduced the role and organisation of the MHRA in regulating medicines and medical devices in the UK. He then discussed, further to 2207/47/EC, the classification of medical devices, including devices incorporating software, and the circumstances in which software (including a mobile app) would be considered a medical device in its own right and how to classify such software. Phil went on to discuss MHRA’s adverse event reporting systems, trends in spontaneous suspected adverse drug reaction reports made to MHRA, why MHRA would like to increase reporting, and the potential role of mobile apps.
The slides are available here (678KB).