Mobile health applications that meet the definition of a medical device within the meaning of Regulation (EU) 2017/745 on medical devices (MDR) must comply with the applicable requirements of this European legislation.
Some mobile health applications may also be reimbursed under the NIHDI reimbursement system. To be eligible for such reimbursement, the application must, among other things, be registered with FAMHP.
The FAMHP takes also part in the evaluation process of those apps within a multidisciplinary working group.
For more information on reimbursement procedures, please consult the NIHDI website.
Notification of a mobile health application to FAMHP
To register a mobile health application with the FAMHP, a notification must be submitted via the FAMHP web portal. Additional information is available on the portal homepage under the "Info & Documentation" section.
The devices must be notified on the FAMHP web portal in the same way in which they are placed on the market.
| Expected notification | |
|---|---|
| Components may be purchased separately as medical devices | If a device consists of a physical component and an application, and each of these components may be purchased separately as a medical device, each device must be notified separately. |
| Components are sold exclusively together | If the physical component and the application are sold exclusively together, a single notification for the complete device is sufficient. |
Document to be submitted
In addition to registration on the portal, the following documents must be sent by e-mail to notifications.meddev@fagg-afmps.be, with the subject line: "Notification - mobile health application - [application name]"
| Documents | Details |
|---|---|
| EU declaration of conformity (DOC) | The declaration of conformity for the application concerned. |
| CE certificate | To be provided where applicable (any device other than class I). |
| Instructions for use |
The instructions for use relating to the mobile health application. Please note: where the application includes a user interface, the instructions for use must be provided in the three national languages (Law of 22 December 2020 on medical devices). |
Verification by the FAMHP
The FAMHP then verifies whether the mobile health application meets the requirements of Regulation (EU) 2017/745. Where the applicable conditions are met, the application is published on the FAMHP web portal and becomes publicly accessible.