MDR: Changing requirements for Health Apps & Medical Software?

The list of available apps that are available in Apple's Appstore or it's counterpart the Google Play Store, is still growing every day. Among them is a popular type of app: health & fitness apps. If your app is one of those, it just might be time to get a little advice or read up on regulations regarding Medical Devices. Why? Because your app might be considered Medical Software.

How do I find out if I have a Medical App?

So, let's say you have an app that is used in a health environments and you want to see what you have gotten yourself into. Plainly, start by asking yourself these two questions:

  1. Is it for specific hardware or a general computing platform?

  2. Is it for Medical Device Use or other Health use?

Subsequently, you'll end up in any of the four categories below. This is important because the implications for your app differ quite a lot and if your app turns out to be classified as ' Software as a Medical Device' (or just: Medical App) you will be faced with a significant burden of regulatory requirements. If it's not, you are off the hook.

Usually, though the answer isn't so black and white and it can be hard to discern between the two categories of apps. You should be asking yourself questions like:

  1. Does it make statements about a disease?

  2. Can the app generate any health claims?

  3. Is the software necessary for a physical Medical Device to function?

If questions like these are answered with 'yes', then you most likely have a Medical App on your hands. So, what now? You'll want to learn about the Medical Device Regulation or abbreviated: MDR.

What is the MDR?

The legislature regarding Medical Devices and thus also all Medical Apps. Depending on when you are reading this article it will replace or will have already replaced the Medical Device Directive. One remarkable difference between the two is that it is far more stringent than its predecessor. Within this document (that is around 170 pages) you can learn about specific requirements for medical apps in particular as well.

Although, some will manage their own compliance needs for the new MDR while others may outsource the entire proces, we recommend to everyone to read the legislature. It might seem complicated and better left to real MDR experts, it can never harm to get a better understanding yourself for requirements thsat affect a product you developed.

How bad is it?

From what we have seen so far, most of the medical apps are classified as class 1and although it is considered urban myth we often get the question: Will my Medical App automatically be classified class as a 2a or 2b Medical Device under the new MDR? So, putting shortly, it is not so bad as it seems and not all is lost.

What does the MDR say about Medical Apps specifically?

The MDR actually has 1 specific rule for Medical Apps (No. 11) or rather the 'classification of software':

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
  • death or an irreversible deterioration of a person’s state of health, in which case it is in class III;

  • or a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.

How do I prepare my Medical App for the MDR?

Help, I. just classified as a 2a or 2b Medical Device! As always, start at the beginning. If you all of the actions below you're are doing alright. Also, keep in mind that you will be required to work with a Notified body gain (or keep) your CE Mark.

  • Determine if your product in within the MDR's scope

  • Classification of your apps's risk class

  • Map relevant differences

  • Risk Classification

  • Conformity Assessment Procedure

  • Write an Implementation Plan

  • Adapt your Product Documentation

  • Review and Adapt your Quality Management System

  • Explore new requirements regarding Post Market Activities and Reporting

Need more tips? We realize that not everyone has the time or energy to get an in-depth overview of the MDR, so if you have any specific questions, feel free to ask us without any obligation. We would be glad to get acqainted.

Blog by: Lupa van Es

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