The NIHDI integrates some mobile medical applications (mobile health applications) into the reimbursement system. To be eligible for this, your mobile application must be registered with the FAMHP.
The FAMHP takes also part in the evaluation process of these applications through the multidisciplinary working group.
Notification of your mobile medical application to the FAMHP
To register your mobile medical application with the FAMHP, you need to submit an application via the FAMHP web portal.
The FAMHP will check whether the mobile medical application complies with the following requirements:
- CE-marking as a medical device;
- Enabling a patient to share health-related information from their own environment (e.g. via sensors) with a healthcare provider;
- Allow a healthcare provider to diagnose, apply therapy or monitor a patient remotely via a medical device designed for use by the patient in his/her own environment.
To verify this, we ask you to provide us with the following documents via email (notifications.meddev@fagg-afmps.be) with the subject line ‘notification – mobile medical application - application name’:
- Declaration of conformity (DOC)
- CE certificate (if applicable)
- Instruction for use (IFU)
- If the application has a user interface, please provide the IFU in the three country languages according to the provisions in the Medical Devices Act of 22 December 2020.
More information can be found here: