Every company selling implants and certain invasive medical devices in Belgium must report the data for these in a notification database. The notification of these medical devices applies as a condition for reimbursement of the obligatory insurance for health care. From June 3, 2019 the notification of these medical devices in the database will occur via a new online application at the Federal Agency for Medicines and Health Products (FAMHP).
One governmental institution for reporting distribution activities of medical devices
Distributors of medical devices already need to register with the FAMHP. The notification of the implants and certain invasive medical devices that they distribute was done, on the other hand, with the RIZIV. Striving for administrative simplification for the companies, both systems will now be covered by one governmental institution. In addition, through this merger, the market oversight and traceability of medical devices can be organized more efficiently.
Online registration still available
The online application for the management of the notifications will be available on the web portal of the FAMHP. The current notifications to the RIZIV will remain available in the new application. From now on, however, the European risk class of the medical device will be requested for each new notification or if when an existing notification is changed. There is a transition period of 1 year for previously reported devices, within which the European risk class must be added. Notification will stop automatically after this period.
Temporary limited availability of the notification database
To make the transition possible, the online application of the RIZIV will be unavailable for entering information:
- Through May 19, 2019 at 12:00, companies with the RIZIV will have access to all of the modules of the online application. After that, the online application will be shut down. All notifications entered through My 15, 2019 will still be processed by the RIZIV. The notifications validated by the companies (article 9 (2) of the RD dated March 1, 2009) before May 19, 2019 at 12:00 will be included in the last publication list of the RIZIV. Anything not validated must be entered again with the FAMHP. Companies must, therefore, enter their notifications in a timely manner.
- On May 19, 2019 at midnight, the RIZIV will make its last publication list with notified devices available.
On June 3, the FAMHP will launch its online application for the management of notifications and the RIZIV will remove the publication list from its website.