Level 1 (M1) determines the basic criteria for an app. Three criteria are applicable:
- CE declaration as a medical device is submitted
- Voluntary notification of the mobile app to the Federal Agency for Medicines and Health Products (FAMHP), during which the CE marking and the compliance with the rules and regulations for medical devices are confirmed and can be checked.
- The app and the parent company declare that they comply with the EU General Data Protection Regulation (GDPR).
Do you want to know more what this rellay means? We refer to specific websites of the FAMHP:
- Definition of a medical device.
- Role of FAMHP wrt medical devices.
- Info about CE marking and Notified Bodies.
- Info about classification of medical devices.
- Notification of an incidence with a medical device.
Level 2 (M2) is based on the interoperability and connectivity to the basic services of the eHealth platform.
Mobile healthcare apps that are approved as M2
- meet the basic criteria of level 1
- have been submitted to a risk assessment (developed by an independent organisation and included in mHealthBelgium) after which they have proven to meet all imposed criteria regarding authentication, security and the use of local e-health services by means of standardised tests (if applicable).
Level 3 (M3) is reserved for apps for which the social-economic added value has been demonstrated and which are financed, after approval by the NIHDI of their funding request.
Download here the procedure and template for an M3 request:
M3 apps always meet all criteria of level 1 and the (applicable) criteria of level 2.
Please note that mobile healthcare apps can also be financed by other means than through the NIHDI. For example, hospitals may have their own financing resources, patients or healthcare professionals may pay for the app themselves or health insurance companies may (partially) support the use of the app.