Mobile health applications with a medical purpose that fall under the definition of a medical device must comply with the requirements of the European Medical Devices Regulation (MDR).
Some of these mobile applications may be included in the reimbursement system by the NIHDI. To be eligible for this, the application must be registered with the FAMHP.
The FAMHP also participates 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 health application with the FAMHP, you need to submit an application via the FAMHP web portal. More information on this matter can be found in the various user guidelines available on the homepage of the web portal under the section “Info & Documentation”. In addition, please send the documents listed below by email to notifications.meddev@fagg-afmps.be, using the subject line ‘Notification – mobile health application – name of the application’:
- Declaration of conformity (DOC)
- CE certificate (if applicable)
- Instruction for use (IFU)
- If the application includes a user interface, the IFU must be provided in the three national languages, in accordance with the provisions of the Medical Devices Act of 22 December 2020.
The devices must be notified on the FAMHP web portal in the same manner as they are placed on the market. If a device consists of a "physical" component and an application, and these parts are also sold separately as medical devices, each device must be notified individually as a mobile health application. When the "physical" device and the application are only sold in combination, only a single notification is required.
The FAMHP will assess whether the application meets the requirements of the MDR. If the conditions are fulfilled, the application will be published on the web portal and made accessible to the public.
For more information on the reimbursement and the additional criteria required by the NIHDI, you can consult their website: more information on the renewed procedure + submitting an application for reimbursement (NIHDI).