The update includes the review and, if necessary, the revision of the definition, the product subgroups as well as the product types including the indications.
The Product group 04 ‘Bath and shower aids’ of the list of medical aids (Hilfsmittelverzeichnis, HMV) was updated by the National Association of Statutory Health Insurance Funds in Germany (GKV-Spitzenverband) . In summary, we note the following relevant changes:
- There is no longer a product type labelled "not occupied". This area has been tidied up and legacy items removed unless they were assigned to other product types in the list of medical aids.
- The scope of delivery of the products "grab rails" and "wall-mounted shower stools" must now include fixing material.
- The requirements for product labelling have been revised and aligned with the MDR-requirements. Attention at this point! Compliance with the MDR requirements continues to form the basis (CE conformity in accordance with the Medical Device Regulation, MDR ). Further requirements, especially for the information in the instructions for use, come from SGB V.
On 11 March 2022, the update of the product group was announced in the Federal Gazette in accordance with Section 139 (1) SGB V.
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