Healthcare apps are becoming a greater part of everyday life. The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices. In the United States, the FDA has issued some guidance on how it will treat healthcare-related apps. However, the FDA’s guidance only provides a list of examples of what constitutes a medical device, leaving the app developers to try and analogize their new apps to the examples or interpret the statutory language.
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has attempted to simplify the regulatory determination for app developers by updating its guidance on classifying health apps as medical devices. As part of the update, the MHRA published a”step-by-step interactive PDF” to assist app developers in determining whether their app will be regulated.
According to the press release, “[a]pp users can use this guidance to check if their health app is a medical device.” The goal of the update is to “aid developers in navigating the regulatory system so they are aware what procedures they need to have in place to get a CE mark which indicates acceptable safety standards and performance, and what their reporting responsibilities are when things change or go wrong.” John Wilkinson, MHRA’s Director of Medical Devices stated:
Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.
To further MHRA’s goal of assisting app developers with CE marking regulation, the interactive PDF provides a flow chart to help app creators determine whether their app could potentially be classified as a medical device.
The interactive PDF also provides additional flow charts for determining whether an app has a medical purpose and whether an app works directly with in vitro diagnostic (IVD) data. Additionally, the interactive PDF also sets forth the “essential requirements” that app developers must meet in the event their app is classified as a medical device. MHRA has inserted explanatory comments into these requirements section that give simple examples or a brief interpretation of the regulatory text. MHRA also provided links in the PDF where app developers can go for additional guidance.