MHRA Updates Guidance on Healthcare Apps as Medical Devices

| Printer friendly version

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.flow chart

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.

Brandon Smith
Brandon Smith is an associate in our Orange County office. His practice is focused on patent litigation and prosecution. Mr. Smith earned his Bachelor's of Science in Biomedical Engineering at California Polytechnic University, San Luis Obispo. Mr. Smith received his J.D. from the University of San Diego School of Law where he was Editor-in-Chief of Volume 52 of the San Diego Law Review. Mr. Smith was a summer associate with the firm in 2014 and joined the firm as an associate in 2015.
Click here to read full bio
View all posts published by Brandon Smith »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.