You have developed a mobile health app, recognized as a medical device?

We invite you to apply to mHealthBelgium by filling the requested information here.

The pyramid and submission consist of three levels:


  • Voluntary notification of the mobile app at the Federal Agency for Medicines and Health Products (FAMHP), thereby confirming the CE marking and compliance with the rules and regulations for medical devices
  • The application and its mother company declare that they are compliant with the EU General Data Protection Regulation (GDPR).


1.Make sure your app is subject to the medical device regulation

2.If your app is a medical device, then check the class to which it belongs

3.Proceed to CE marking

4.Register your company AND notify your product in Belgium (FAMHP)

You are now M1 candidate for mHealthBelgium. Before registering your app on the platform, make sure you have your FAMHP number and CE certificate


  • The app must comply with the level 1 before applying this stage.
  • The app will have to perform a risk assessment and be tested (by an independent organization), if applicable, on basic services of the Federal eHealth Platform. Applicable basic services, such as, authentication, identification, relationship or security. Download the technical requirements¬†here.


1.Your app received a level 1 approval and you become a level 2 candidate

2.mHealthBelgium invites you to perform an online risk assessment (which is included in what you get by subscribing to mHealthBelgium.

3.Based on your risk assessment you receive a list of basic eHealth services you need to be connected to

4.You test your connectivity to these eHealth services, via an independent test center performing mini-labs

5.You get a report showing your connectivity level

6.Based on this report and number of successful tests, your app gets level 2


Level 3 is reserved for applications which have proven clinical and health economic benefit, but also promising technology warranting temporary financing to collect the data. Other means of funding? Mobile health applications can also be financed by other means than the NIHDI. For instance, hospitals could finance them out of their budgets, patients or healthcare professionals could finance the application out of pocket, or sick funds could (partially) support the use of the app.


1.Your app received a level 2 approval and you can now decide to become a level 3 candidate

2.You receive a NIHDI template to be filled in, in which you provide clinical and health-economic data and evidence that support your funding request

3.You submit it to NIHDI and enter the process

4.NIHDI will give you a feedback on the status of your request (submitted, accepted for review, approved or declined) and a timeline

5.Based on the feeback you get from NIHDI, mHealthBelgium validates (or does not) your level 3

Close Menu