Medical Technical Aids Register (HMV)

In Germany, only registered medical devices are covered by statutory health insurance funds. The German Medical Technical Aids Register (Hilfsmittelverzeichnis, or HMV) is drawn up and updated by National Association of Statutory Health Insurance Funds (GKV Spitzenverband, or GKV). Requirements relating to the quality of devices and of care are set out Sections 33 and 34 of Book V of the German Social Code (Sozialgesetzbuch – SGB V).

Under the German system, medical devices can only be issued to patients via service providers (medical supply stores). In order to ensure that costs are reimbursed quickly and easily, service providers will need an individual HMV code for your device. In order to obtain this registration number, your device must meet the specific device and documentation-related requirements set by the National Association of Statutory Insurance Funds.

Topics

Entitlement to Benefits

Inspection reports

User Manuals

Application procedures

Testing

Digital healthcare applications (DiGA)

Entitlement to Benefits

The German Social Code (Sozialgesetzbuch – SGB) contains provisions regulating whether statutory health insurers in Germany (i.e. the GKV) are required to provide insurance benefits in respect of your device. There are a number of issues to consider and take into account in this regard.

Together with our legal experts and network partners, we can help you to clarify these issues, thus strengthening your legal claim to a registration number for your product.

User Manuals

You may already be fully compliant with the CE requirements for user manuals under the Medical Devices Regulation and various other standards. However, in order to obtain a medical device registration number in Germany, you must also comply with German welfare legislation.

We can highlight the additional information German statutory health insurers require your device can be listed, and thus become eligible for reimbursement of costs.

Testing

Test reports are indispensable evidence that your device is suitable for its claimed purpose. It is not always obvious exactly what tests are required before you are accepted by the GKV, or where they should be carried out. Our knowledge of testing standards and experience of testing procedures can give you a decisive edge in this regard.

Our experts will be happy to advise you on every aspect of the relevant testing procedures.

Test Reports

The medical benefits of medical devices with therapeutic effect must be evidenced according to the requirements of the German National Association of Statutory Health Insurance Funds (GKV). Evidence is generally provided via small-scale case studies, the results of which are summarised in an case report by independent medical specialists.

We have over 20 years of experience in inspection reports of this kind, and will be happy to provide you with detailed, specific advice.

Application Procedures

The process of applying for an HMV code and getting your device listed in the German Medical Technical Aids Register (HMV) is highly formalised, and can prove difficult to navigate.

We work on well over a hundred applications every year. Trust our experts to provide you with sound advice at any stage before or during the process.

Digital Healthcare Applications (DiGA)

Since 2020, changes to regulations have made it easier to get costs associated with digital healthcare applications (known in Germany by the acronym DiGA) reimbursed by statutory health insurers in Germany. However, the BfArM evaluation procedure must be prepared for well in advance.

Registering a digital healthcare application is a big step. Let us help you plan it.