Market Access Strategy for Medical Devices in Europe
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Implantable cardiac defibrillation devices added to the Belgian List of implants and invasive devices
On December 5, 2025, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) updated the List of implants and invasive medical devices effective January 1, 2026.
Previously, implantable cardiac defibrillation devices (ICD, CRT-D, subcutaneous cardiac defibrillators, and electrodes) were not included in the regular reimbursement mechanism via the INAMI/RIZIV List of implants and invasive medical devices; instead, they were included in a separate list of eligible devices in connection with a specific agreement (Convention) between INAMI/RIZIV and hospitals.
A new section F.1.12. “Cardiac defibrillator” was added the List of implants and invasive medical devices with 15 new material codes for single-chamber cardioverter defibrillators (ICD), dual-chamber ICD, cardiac resynchronization therapy defibrillators (CRT-D), subcutaneous cardiac defibrillators, and electrodes. Some examples of new codes are provided below:
- 186734-186745 “First single-chamber cardiac defibrillator, adapter included” with a tariff of €10,372.74;
- 186911-186922 “First subcutaneous cardiac defibrillator, adapter included” with a tariff of €13,104.39;
- 186992-187003 “Resynchronization electrode for a cardiac resynchronization defibrillator, per electrode”, with a tariff of €1,110.21.
A new Nominative list 404/Cardiac defibrillators was created with multiple registered branded devices in connection with new material codes for cardiac defibrillators. For electrodes, brand-specific registration on the Nominative list is not required.
See the full details in French here and in Dutch here.
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