To encourage competition among the statutory health insurance funds, a new law entered into force on 1 April 2007. Further changes for medical aid provision were defined in the laws for the development of organizational structures in statutory health insurance, 1 January 2009. Later, further organizational and contract-related conditions were defined. Among others, these laws introduced the following requirements.
- The introduction of a so-called centralized prequalification process of health-care providers
- Medical-device tender modification: from “should” to “able to”-provisions
- Recommendation on functionality of medical device tenders
- Introduction of membership right of health care providers to existing medical device contracts
Health aids are materials or medical services which can be covered by the German statutory health insurance. Medical-device manufacturers and health-care providers have to carefully follow the service and product quality requirements as they are stated in the German Health Aid List (Hilfsmittelverzeichnis – HMV). The legal basis for HMV remains to be the German Social Legal Code (Sozialgesetzbuch - SGB) §33 and § 34.
In order to register a medical device in the HMV and thereby fulfil its requirements, manufacturers have to overcome various obstacles. The Association of Statutory Insurance Funds (Gesetzliche Krankenversicherung Spitzenverband) expects a complete and spotless submission of proofs and certificates which satisfies the requirements and quality of the distributors. Mistakes in the registration documents can lead to delays in market entry as well as tender processes. BEO BERLIN® can help you avoid such mistakes.
Since 2003, we have assisted and successfully registered 2500 medical devices. After successful registration, the product receives a 10-digit HMV-number, which can make sales activities and communication with health-care providers easier.
- Initial product conformity test
- Document supervision for completeness and appropriateness
- Product design conformity advice
- User manual, risk analysis, clinical studies etc. preparation
- Testing and expert appraisal coordination, where applicable
- Contact person and representative
- Registration package submission
- Individually tailored process
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