Requests are handled by the CTIIMH (Commissie voor terugbetaling van implantaten en invasieve medische hulpmiddelen in Dutch) or CRIDMI (Commission de remboursement des implants et des dispositifs médicaux invasif in French) of the Belgian National Institute for Health and Disability Insurance (NIHDI or INAMI / RIZIV).
Our blog breaks down how the CTIIMH/ CRIDMI handles applications, what types of files exist, and what steps are involved.
The Belgian Healthcare System: A Structured but Complex Environment
Belgium operates a compulsory social health insurance system based on the Bismarck model, built on three core principles: universal coverage, freedom of choice for patients, and independent medical practice predominantly financed through fee-for-service. Approximately two-thirds of healthcare funding comes from social security contributions (employers, employees, self-employed and civil servants), with the remaining third financed through general taxation and patient co-payments. Coverage is nearly universal, with 99% of the population insured under the compulsory scheme. The National Institute for Health and Disability Insurance (INAMI/RIZIV) oversees the system, allocating budgets to the non-profit sickness funds (mutualités/mutualiteiten), which manage reimbursements and interact closely with policymakers. While all sickness funds offer identical compulsory coverage, they compete through service quality and supplementary insurance offerings. In a system strongly focused on cost containment, particularly for pharmaceuticals and medical devices, obtaining reimbursement requires a clear strategy and deep understanding of regulatory and budgetary dynamics.
Reimbursement for medical devices
Basically, reimbursement for medical devices is managed by two key committees within the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV).
CRPPP (Commission de remboursement des produits et des prestations pharmaceutiques in French) or CTFPV (Commissie voor Terugbetaling van Farmaceutische Producten en Verstrekkingen in Dutch): oversees applications for non-implantable and non-invasive devices. The Royal Decree of 23 November 2021 defines the process, criteria, and timelines for reimbursement decisions in this category.
CTIIMH (Commissie voor terugbetaling van implantaten en invasieve medische hulpmiddelen in Dutch) or CRIDMI (in French) handles requests for implantable and invasive medical devices. The procedures, conditions, and timelines for these devices were formalised under the Royal Decree of 25 June 2014.
Positive List
The “Positive List” for Implants and Invasive Medical Devices
Reimbursement of implants and invasive medical devices in Belgium is based on a so-called “positive list”. Only devices that fall within this list are eligible for reimbursement under the compulsory health insurance system.
This list includes:
- All reimbursed implants and invasive medical devices
- 13 chapters (A to M), each divided into sub-chapters
- More than 1,000 reimbursable items (“verstrekkingen” in dutch), each identified by a unique number and a generic description
- Detailed reimbursement conditions, including:
- Reimbursement categories
- Eligibility criteria
- Administrative forms and procedural requirements
- Registration obligations
Importantly, an entry (“verstrekking” in Dutch) on the positive list is generic. It does not refer to a specific brand or manufacturer. Instead, it describes a general type of implant or invasive device that meets predefined technical and clinical criteria.
Nominative List
Each generic reimbursement item can be linked to a nominative list.
- The Positive List defines what type of device can be reimbursed.
- The Nominative List specifies which individual devices (from specific distributors or manufacturers) are approved and eligible under that generic reimbursement code.
In other words, the positive list sets the framework, while the nominative list confirms whether a specific product can actually be reimbursed. Please note that not all reimbursable devices are linked to a nominative list. Certain reimbursement items are not subject to nominative listing, meaning that all devices meeting the defined criteria are eligible for reimbursement without the need to be individually added to a positive list.
For certain technologies, such as implantable cardioverter defibrillators, a separate dedicated list applies.
For detailed and up-to-date information, stakeholders must consult the sIMPL database, which contains the official data linked to reimbursed devices.
Reimbursement Categories for Implants and Invasive Medical Devices
The reimbursement categories define how INAMI/RIZIV reimburses the device and who bears the financial risk when prices exceed thresholds. Understanding these categories is essential for manufacturers when defining pricing, market access strategy, and hospital negotiations.
- Category A: Reimbursed based on the individual price when they are included in a nominative list.
- Category B: Reimbursed on a non-lump-sum basis without being included in a nominative list.
- Category C: Reimbursed on a non-lump-sum basis when they are included in a nominative list.
- Category D: Reimbursed on a lump-sum basis without being included in a nominative list.
- Category E: Reimbursed on a lump-sum basis when they are included in a nominative list.
- Specific Situations: Certain reimbursement items fall under specific regulatory frameworks:
- Category F: Reimbursed based on the sales price including VAT.
- Category G: Reimbursed within the framework of a “Limited Clinical Application.”
- Category H: Reimbursed within the framework of a contract concluded with the Institute.
These specific situations often involve additional procedural requirements, timelines, and negotiation dynamics.
Submitting Applications to IRREQ
Reimbursement applications for implants and invasive medical devices must be submitted through IRREQ (Implants Request & Reimbursement Electronic Questionnaire), the official electronic platform managed by RIZIV/INAMI.
IRREQ is the mandatory submission portal for manufacturers and distributors seeking:
- Application for change of the list
- Adding a device on a nominative list
- Modification of existing reimbursement conditions
- Price changes
- Transfer of distribution rights
- Extension or restriction of indications
The application must be submitted by the legal distributor or marketing authorization holder established in Belgium. The applicant must be registered with RIZIV/INAMI and have access credentials to the IRREQ platform.
Timelines depend on the complexity of the request and the reimbursement pathway.
Required Documentation
Although requirements vary depending on the application type, submissions generally include:
- CE certificate and Declaration of Conformity
- Technical description of the device
- Clinical evidence supporting safety and effectiveness
- Proposed reimbursement category and justification
- Budget impact analysis where applicable
- Comparative data (if relevant)
Incomplete submissions can delay the evaluation process.
At LIVV, we specialize in guiding companies through every step of the reimbursement pathway. From dossier strategy and preparation to liaising with working groups and regulatory follow-up, we ensure your file is clear, compliant, and positioned for success.
Don’t leave your reimbursement to chance, partner with LIVV for peace of mind and proven expertise.
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