The UK’s Medicines and Healthcare products Regulatory Agency is providing guidance to manufacturers about when stand-alone software may be considered a medical device.
In the UK and Europe, stand-alone software and applications that meet the definition of a medical device are still required to be CE marked, the agency said in guidance released Aug. 25.
The guidance is provided in the form of an interactive slide presentation that directs manufacturers and users to a decision tree to help inform them about whether the app would be considered a device or not.
For software developers, the guidance includes information on classification of devices as well as suggestions on how to address the main aspects of the CE marking process.
For users, the agency offers tips on how to decide if the app or software is a medical device as well as how to ensure it is CE marked and how to report problems. — Tamra Sami