An update of the product groups in the list of therapeutic appliances of the GKV-Spitzenverband (GKV-SV) includes the review and, if necessary, the revision of the definitions, the product subgroups and the product types including the indications.
The National Association of Statutory Health Insurance Funds ind Germany (GKV-Spitzenverband) announced in the Federal Gazette the update of product group 17, on June 6th and the update of product group 17 and on June 14, 2023, the update of the product group 20 announced in the Federal Gazette.
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 due to an update and doesn't get deleted.
Significant changes are:
PG 03 Application Aids
- The “Definitions” were adapted editorially and to the current medical status.
- 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”
- Further editorial changes/precisions/adjustments
PG 17 Aids for Compression Therapy
- Addition of the included aids in the PG: Head / thoracic lymphoedema compression bandages.
- The “Definitions”, “Delimitations” and “Indications” have been adapted editorially and to the current medical status.
- 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
- Minor amendment of the “Quality requirements with regard to service life
- Minor amendment of the “product information requirements”.
- Amendment of the “Service Requirements”
- Further editorial changes/precisions/adjustments
PG 20 Positioning Aids
- The “Definitions” have been editorially revised.
- Adaptation of “Functional Capability and Safety” following the regulations of the Medical Devices EU Adaptation Act (MPEUAnpG)
- Adaptation of the wording and specification of “indication and use-related quality requirements” in various product subgroups
- Amendment of the “Product Information Requirements”
- Changes to the service requirements to align the product groups
- Further editorial changes/precisions/adjustments
PG 21 Measuring Devices for Bodily States and Functions
- The “Definitions” were adapted editorially and to the current medical status.
- 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 “Quality requirements with regard to reuse”.
- Amendment of the “Product Information Requirements”
- Amendment of the “Service Requirements”
- Further editorial changes/precisions/adjustments
PG 30 Glucose Management Devices
- Information on the status of comments received was published
The GKV-Spitzenverband also intends to update the product groups 11 “Aids against decubitus”, 14 “Inhalation and respiratory therapy devices”, 24 “Leg prostheses” of the list of aids. MTD-Instant 24 / 25 / 2023 reported that the commenting procedure had been initiated with the submission of the draft product groups. The deadlines for comments end on July 17th, 2023 (PG 11), July 28th, 2023 (PG24) and August 15th, 2023 (PG 14).
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