Notification procedure for implants and invasive medical devices to obtain reimbursement in Belgium

Notification is a condition for obtaining reimbursement of compulsory medical insurance for implants and invasive medical devices for long-term use. Only devices that meet the notification requirements will be eligible for health care insurance. The claim file can be received only if the devices are notified.

Devices that are not notified when they are subject to the notification conditions will not be able to be billed to patients. When the patient is hospitalized, these devices will be entirely within the budget of the financial resources of the hospital.

This notification does not constitute an assessment of the quality of the products already available on the market but allows compulsory health care insurance to have an overview of all existing devices already on the market. Knowledge of the available devices is a start for proper support. From this point of view, the notification procedure also fits with the goal of better protection of patients against supplements.

Since the 3rd of June 2019, the notification is made via an online application available on the portal site of the Belgian Federal Agency for Medicines and Health Products  (AFMPS).

The following categories of devices, as laid down in the Royal Decree, must be notified:

• implantable devices
• invasive devices

The following types of devices, set out in the Royal Decree, must not be notified:

• dentures
• customized devices – any device manufactured expressly by the written prescription of any person authorized by national law under his professional qualifications, indicating, under his responsibility, the specific design features, and intended to be used only for a particular purpose
• devices subject to clinical investigation
• all suture and ligation material except vascular suture devices and cerebral aneurysm clips

See full details in French here.

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