A lot has changed in the reimbursement of medical devices in Germany in recent years. Manufacturers of medical devices in the home care sector, especially in the field of orthopaedic and rehabilitation technology, have to deal with new regulations and requirements. In this article, we provide an overview of the most important changes and explain the resulting recommended actions.
What is the list of medical aids and what role does the position number play?
The German Medical Technical Aids Register. is a list of medical devices that are reimbursed by the statutory health insurance funds. In order to be included, certain requirements must be met. These include authorisation as a medical device and the fulfilment of quality and safety requirements.
The item number, also known as the medical aid number or Hi-Mi number, plays an important role in the medical aid catalogue. This number identifies a medical device and indicates the position under which it is listed in the medical aids catalogue. The item number determines whether a product is eligible for reimbursement and which requirements it must fulfil. It is assigned by the National Association of Statutory Health Insurance Funds (GKV-SV) on the basis of the requirements of the medical aids directory and the applicable laws and regulations. The item numbers are assigned by a panel of experts from the GKV-SV. This committee consists of representatives of the health insurance funds, manufacturers and professional associations.
Manufacturers of medical devices must ensure that their products have the correct position number and fulfil the requirements of the respective position in order to remain eligible for reimbursement. To ensure that their products have the correct position number, manufacturers should regularly monitor the changes. Detailed information on further technical terms can be found in our Glossary.
Changes to the list of medical aids
One of the most important changes is the implementation of the Medical Device Regulation (MDR)One of the most important changes is the implementation of the Medical Device Regulation (MDR). This EU Directive regulates the market access and monitoring of medical devices and came into force in May 2017. For manufacturers, this means that they must have their products recertified in order to remain listed or be included in the register. As a result, they now bear greater responsibility for the safety and quality of their products and must prove this accordingly.
As a manufacturer of medical devices in the home care sector, you need to consider the new regulations and requirements. This includes certifying your products in accordance with the MDR. It may also be necessary to adjust your products to the new requirements in the medical aids catalogue in order to remain eligible for reimbursement.
Another challenge is the assessment of the products by the health insurance companies' experts. They check whether the products fulfil the requirements of the list of medical aids and whether they are eligible for reimbursement. This process can be complex and time-consuming and requires in-depth knowledge of the requirements and regulations.
How can you prepare for the changes?
As a manufacturer of medical devices, it is important to consider the changes at an early stage. One option is to use service providers who can support you with the certification and registration of your products. Working with experts in the field of medical device reimbursement can also be helpful.
Die BEO BERLIN ist ein solcher Dienstleister und hilft Ihnen bei der Registrierung und Listung Ihrer Produkte im Hilfsmittelverzeichnis. Wir beraten Sie zu den Anforderungen und Regelungen und unterstützen Sie bei der Zertifizierung und Registrierung Ihrer Produkte. Weitere Informationen finden Sie hier.
Conclusion
To conclude, it can be said that the reimbursement of medical devices in Germany, is a complex and constantly changing topic, especially for manufacturers of medical devices in the home care sector. It is important to consider the requirements and regulations in the medical aids directory at an early stage in order to remain successfully listed and eligible for reimbursement.
If you have any questions about the changes or need support with the certification and registration of your products, please do not hesitate to contact us. We are at your disposal with our expertise and experience.
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