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:

Level 1 sets the basic criteria for an application. Applied criteria:

  • 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).

Level 2 is based on interoperability and links to basic eHealth platform services.

To submit a request to register a mobile app at this level, the app must comply with the level 1 requirements and report on several tests. The app will have to perform a risk assessment (performed by an independent organization) and be tested on authentication, security and use of eHealth local services (if applicable). Download the technical requirements here.

Level 3 is reserved for applications which have proven clinical and health economic benefit. These applications must also meet all level 1 criteria and the (applicable) level 2 criteria. A funding procedure is currently under development by the NIHDI (Belgian National Institute for Health and Disability Insurance (RIZIV/INAMI)) for mobile health applications that have the clinical and health-economic data available to support such a funding request. Level 3 provides information on the status (submitted, accepted for review, approved, declined) of the NIHDI funding request and on the timelines of the procedure.

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.

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