How to check if your app is a medical device and meets the necessary legal requirements?

Identifying an app as a medical device can be very tricky. That is because the app must meet several qualification criteria, stated in the Medical Device Directive. They determine the safeness and compliance of the app with the European regulatory framework.

So, if you're a manufacturer of an app, there are five main qualification criteria that your app should comply with to be defined as a medical device. These criteria are the medical purpose, office programs and operating systems, hardware, software via the Internet, and cell phone apps. Continue reading to learn more about each one of them.

Criterion 1: Medical purpose

First of all, your app should have a medical purpose. You, as a manufacturer, are responsible for defining it. The medical purpose determines the intended use of the app. According to Article 1 of the Medical Device Directive 93/42/EEC, the medical purpose could be:

• Diagnosis, prevention, observation, treatment or alleviation of diseases;
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
• Investigation, modification or replacement of the anatomy or a physiological process;
• Control of conception.

Moreover, stating the medical purpose of your app is not enough to meet this qualification criterion. Additionally, you must ensure that:

• The app has all the necessary features for supporting its intended usage;
• The app’s performance has been evaluated and determined to meet its defined medical purpose;
• The use of the app should involve a patient whose safety has been considered in a risk management process;
• The app must pass the CE marking process and be CE marked before being released on the market.

Besides all above, your app must be accompanied with detailed and clear instructions about its features and modes of software.

Criterion 2: Office programs and operating systems

The type of operating systems or virtual environment of your app doesn’t, in fact, impact its compliance as a medical device. Yet, if you intend your app to be used, after being combined with other devices or equipment, then you must ensure that the whole combination is safe and it doesn’t reduce the specified performance of any of the linked elements. Your app’s label and instructions must specify any existing restrictions on use.

Criterion 3: Hardware

The compliance of your app as a medical device can’t be affected by the type of hardware. The hardware is usually not a medical device. For instance, it could be a computer, a network, a server, etc. Yet, the importance of the hardware is due to its impact on the usability of your app. In this regard, you must provide a detailed description of the proper functioning of your app, ergo including hardware’s recommendations. Your sole responsibility is in describing the requirements for a suitable hardware environment and the need for regular safety measures. How the users will use the product depends only on them, and you bear no responsibility.

Criterion 4: Software via the Internet

If your app is available to the users via the Internet or other commercial service setups, and it fulfils the definition of a medical device, then you can define it as a medical device and have it CE marked. The same applies in case your app is usable only via an online server. As a manufacturer, you are responsible for meeting these requirements.

Criterion 5: Cell phone apps

The regulatory framework on cell phone apps is less familiar for the manufacturers of apps. Thus, if you are a manufacturer of a cell phone app with a medical purpose, then it’s good to know that the requirement here is to CE mark your app. Cell phone apps that need to pass the CE marking process are, such as:

• Apps, transferring data from the human body to give a diagnosis to influence the individual’s health. For example, collecting data about body temperature, pulse, weight, etc. The data collection could happen through a body contact sensor, an implanted sensor, or being entered manually.
• Apps used to support medical treatment. Their purpose is to coach the user to follow some given health care recommendations and later communicate the results to their healthcare provider.

Cell phone apps are small applications. Users can usually run them by using a laptop, a tablet or a mobile phone. In other words, they are often part of a broader and more complex digital environment. The users of such apps are healthcare staff, patients, and non-professionals.

Individual cases: Apps as medical devices but without being CE marked

Some apps are developed for manufacturer-only use, and they aren't subject to CE marking. Yet, they still need to fulfil the Medical Device Directive requirements. Those apps should be used only by the person who developed them. They don’t need to be CE marked because they won’t be placed on the EU market. But, they still must follow the requirements for the safety of their software and of their routines and processes. If you have such apps and plan to sell, donate or share them to third parties, then you need to CE mark them before doing it.

Features of apps that don’t count as qualification criteria

The name, technical description, real use and risks of your app can’t be seen as qualification criteria. The reasons are simple:

• How you name your app doesn’t impact in any way its medical purpose and intended use.
• The technical description itself is not enough to determine that the app is a medical device.
• You should always state how users should use your app, but you cannot guarantee the users will follow your recommendations.
• Any risks associated with your app are not qualifying conditions.

With this, our review on the topic ends. Just make sure you're following all abovementioned criteria, and you won't have any legal problems in defining your app as a medical device. We hope you enjoyed it. Feel free to share it with others, so they can also learn how to define their app as a medical device.

If you have any further questions about medical devices, CE marking or the European regulatory framework, please get in contact with us.

Global Product Certification Services (FDA, FCC, CE marking and CB Scheme)