The National Association of Statutory Health Insurance Funds in Germany (GKV-Spitzenverband) announced the update of product group 02 in the Federal Gazette on July 9th, 2023.
A update includes the review and, if necessary, the revision of the definitions, the product subgroups as well as the product types including the indications.
Requirements, evidence management and entire structures and categorisations may change during an update. It is worthwhile to regularly check whether a product that was rejected yesterday is not listable today. On the other hand, you must ensure that your products are not deleted due to an update.
Major Changes PG 02 Adaptation Aids are:
- New product subgroup: 02.40.08 Electrically operated semi-/fully automated feeding robots.
- New product type: 02.40.08.0 Semi-automated feeding robots
- New product type: 02.40.02.8 Eating aids for impaired hand function and non-handedness
- New product type: 02.40.02.9 Eating aids for tremor
- Merger of the two product types for sucking and drinking aids
- Product type: 02.99.02.2 Blow or blow-suck control is deleted
- Adaptation of “Functional Capability and Safety” following the regulations of the Medical Devices EU Adaptation Act (MPEUAnpG)
- Amendment of the “Indication- and use-related quality requirements” in various product subgroups
- Amendment of the “Product Information Requirements”
- Amendment of the “Service Requirements”
- Weitere Redaktionelle Änderungen/Präzisierungen/Angleichunge
Furthermore the National Association of Statutory Health Insurance Funds in Germany (GKV-Spitzenverband) intends to update PG 18 (vehicles for the sick/disabled) of the list of medical aids (Hilfsmittelverzeichnis, HMV) For this purpose, the commenting procedure was initiated by submitting the draft product group. The deadline for comments from patients’ interest groups is September 15th, 2023.
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