For devices patients use at home — from walking aids to incontinence, stoma and compression products — reimbursement runs through a national register. Listing gets you into the catalogue. Contracts, and possibly tenders again, decide the price.
The Hilfsmittelverzeichnis (HMV) is the register of medical aids covered by German statutory health insurance, kept by the GKV-Spitzenverband under §139 SGB V: 42 product groups and about 47,800 listed products. The manufacturer applies online, in German, proving functional suitability, safety, the product group’s quality requirements and, where required, medical benefit. The decision is due within three months of a complete file. Listing is not a price: patients are supplied by pre-qualified providers under contracts with the insurers (§127). A 2026 law passed by the Bundestag would bring back tenders for aids; the Bundesrat deals with it on 20 November 2026.
Statutory insurers pay for medical aids “in principle only” if they are listed. Formally the register is not binding on them, but case law treats it as defining what patients are entitled to — so in practice it steers the market.
It is structured as product group → sub-group → product type → individual product, with a 10-digit position number for each listed product. The sub-groups set the quality and service requirements that the insurers’ supply contracts must build on. In the year to 28 February 2026 the GKV-Spitzenverband counted 42 product groups, 47,825 listed aids, 4,438 listing applications and 3,722 new listings. A separate register for long-term-care aids is attached.
| Requirement | How it is usually shown |
|---|---|
| Functional suitability and safety | The CE mark normally counts as proof; the GKV-Spitzenverband checks the declaration of conformity and notified-body certificates and can test further |
| Quality requirements of the product group | Test reports and certificates meeting the sub-group’s specific criteria, valid when filed and relating to use at home |
| Medical benefit (where required) | Studies from a full international literature search; listing can be limited to the indications where benefit is shown |
| Service requirements | Information the provider needs to supply, fit and support the product |
The GKV-Spitzenverband can ask the Medical Service (Medizinischer Dienst) to check the requirements. If the aid may be an inseparable part of a new treatment method, it refers the question to the G-BA, which has six months to answer — and a full method assessment can follow. Innovative products that fit no existing product type can be listed provisionally under a placeholder type.
The register says what may be supplied. Who supplies it, and at what price, is decided elsewhere.
For a manufacturer, the customer is the provider network — and the price is set in contracts you are not party to.
Getting the category right first saves months. See medical device reimbursement by care setting.
The register of medical aids covered by German statutory health insurance, kept by the GKV-Spitzenverband under Section 139 SGB V. It lists about 47,800 products in 42 product groups and sets quality requirements for each group.
The manufacturer, or a third party it authorises in writing. Applications are made online through the GKV-Spitzenverband’s HMV portal, in German.
The GKV-Spitzenverband must decide within three months of a complete file. Completeness is checked within ten weeks, and missing documents can take up to six months, so plan for several months to a year in practice.
It normally counts as proof of functional suitability and safety, but you must also meet the product group’s quality requirements and, where required, prove medical benefit for use at home.
The emergency-care reform passed by the Bundestag on 15 October 2026 reintroduces tenders where appropriate, with quality weighted at least 50%. The Bundesrat deals with the law on 20 November 2026; industry is asking it to stop or narrow the change.
We map your product group and requirements, prepare the German application, and build the provider and insurer-contract route that turns a listing into revenue.