Introduction: What is the German Medical Technical Aids Register?
The German Medical Technical Aids Register (in German ’Hilfsmittelverzeichnis’ – HMV) is a list of reimbursable medical aids in the German healthcare system. It is managed by the German National Association of Statutory Health Insurance Funds (GKV-SV), the umbrella organisation of statutory health insurance funds, and simplifies billing with statutory health insurance funds.
For manufacturers of medical devices (hereinafter referred to as ‘products’), the inclusion of their medical aids in the HMV is of central importance: for products that are not included in this list, it is significantly more difficult to obtain reimbursement from statutory health insurance funds.
Many European countries have their own national reimbursement lists or procedures for certifying recognised or reimbursable medical aids. The German HMV, for example, provides a standardised, transparent basis for billing medical aids in the statutory health insurance system.
Why Should the HMV be Relevant to International Manufacturers?
The HMV offers advantages for international manufacturers who wish to distribute their products in Germany:
- Simplified market entry: Inclusion in the HMV signals to health insurance companies, service providers and patients that the product meets regulatory requirements, complies with GKV-SV quality standards and is eligible for reimbursement.
- Reimbursability as a competitive advantage: For products that are not listed in the HMV, obtaining reimbursement is significantly more difficult. Service providers must submit individual applications for reimbursement to the health insurance companies. Understandably, service providers would prefer to avoid this unpaid, additional work if comparable products with HMV numbers are available. In this case, no individual application needs to be submitted.
- Stronger market presence: An HMV listing increases the chances that service providers will include the product in their portfolio and make it available to users.
Requirements for Products to be Listed in the HMV
The inclusion of a medical device in the HMV is subject to a number of regulatory and qualitative requirements:
- Regulatory conformity: The product must comply with the requirements of the EU Medical Devices Regulation (EU-MDR) or other applicable regulations
- Minimum technical and functional standards: The GKV-SV defines specific requirements for safety, functionality, features and quality for each product group.
- Proof of compliance with GKV-SV quality standards: Where applicable, this includes a users manual, test reports, manufacturer's declarations, user observations and other documents which prove the functionality, durability and properties of the product.
The Application Process for Admission to the HMV
The path to HMV listing is formalised and requires detailed preparation. We have summarised the steps for you:
- 1. Examination of the product group
Before submitting an application, it must be checked whether the product can be assigned to an existing product group in the HMV or whether a new category is required.
- 2. Compilation of application documents
The key documents include:
- Product description and technical specifications
- Declaration of Conformity (e.g. EC-declaration according to the EU-MDR)
- Evidence-based proof of effectiveness
- Instructions for use and training documentation
- Manufacturer's declarations on specific aspects
- 3. Submission of the application to the GKV-SV
The application is submitted online via a licensed platform directly to the GKV-SV. Any and all commication with the GKV-SV is also handled through this licensed platform.
- 4. Review and decision
The GKV-SV audits the application with regard to completeness and conformity. If necessary additional documents and evidence can be requested. But the processing time of the applicating within the GKV-SV can vary between multiple weeks and even months.
- 5. Inclusion in the HMV or rejection
If the GKV-SV approves the application, the product is categorized and listed in the HMV.
If the application is rejected, manufacturers have the right to a hearing where they can defend their application against any reasons for denial. If manufacturers manage to defend their application, the product will also be listed. If not, the entire application procedure will be terminated without further consequences.
Significance of Updates in the HMV
The HMV is not carved in stone – it is regularly revised. Thus, manufacturers have to follow the ongoing updates of the HMV to make sure their product continue to be listed in the HMV. If a relevant update is announced, manufacturers usually have to submit additional documentary proof of the continued compliance with HMV regulation within a specified time period.
Typical changes include:
- New quality requirements for existing product groups
- Changes in the classification or naming of assistive devices
- Introduction of new product groups or discontinuation of obsolete groups
If manufacturers fail to submit a relevant update, this may mean that their product is no longer HMV-listed, making it significantly more difficult to obtain a reimbursement.
Conclusion and Recommendation for International Manufacturers
For international companies, the HMV is a key factor for successful market entry in Germany. Without a listing, reimbursement is significantly more difficult, which complicates access to service providers/distributors and patients.
Recommendations for Manufacturers
- Early strategic planning: HMV listing should be taken into account in the market entry strategy.
- Detailed documentation: All required evidence must be carefully prepared to avoid delays or rejections.
- Monitoring updates: Changes to the HMV must be reviewed regularly to ensure the long-term reimbursability of listed products.
- Collaboration with experts: As the application process is complex, support from specialised consulting firms such as BEO BERLIN can speed up and facilitate the process.
BEO BERLIN – Your Expert For Getting Your Product Into The HMV
We guide you through the entire process, from preparing the application to providing strategic advice – based on pragmatism, partnership, professionalism.
Contact us, to learn more about your possibilities in the german healthcare market!
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