In Europe, standalone software and apps that meet the definition of a medical device are still required to be CE marked in line with the EU Medical Device Directives to ensure they are regulated, acceptably safe, and perform as intended.
These standalone software and apps gather data from a person or a diagnostic device, such as diet, heartbeat, or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine, or recommend treatment.
On 25th August 2016, the MHRA published an updated, interactive, step-by-step guidance to help correctly identify whether a health app is a medical device. This guidance can be found using the following link:
If you have an app or software with a medical purpose, and are unsure whether the product falls under the category of a medical device, speak with a member of the Medical Device team at Regulis who can help you navigate the regulatory system, ensure you have met the correct safety and performance standards, and advise you on your reporting responsibilities (if applicable).