PG 14 "Inhalation and respiratory therapy devices" has been updated in the German medical technical aids directory. The update of the product group was published in the Federal Gazette according to § 139 (1) SGB V on 09.01.2024.
The following changes should be noted in addition to the editorial revisions:
Deletions:
- Deletion of the product type: 14.24.04.3 "Combined oxygen concentrators and pressurised gas filling units".
- No products are listed and this product type is therefore dispensable.
- Cancellation of the product type: 14.24.04.7 "Combined oxygen concentrators and pressurised gas filling units including oxygen saving system with monitoring device".
- No products are listed and this product type is therefore dispensable.
- Cancellation of the product type: 14.24.04.8 "Combined oxygen concentrators and pressurised gas filling units including oxygen saving system without monitoring device".
- No products are listed and this product type is therefore dispensable.
- Cancellation of the product type: 14.24.06.5 NN "portable/mobile oxygen concentrators up to 5 kg".
- The listed products have been regrouped into product type 14.24.06.4.
- Cancellation of the product type: 14.24.08.2.
- Not occupied and therefore dispensable
- Cancellation of the product type:14.24.17.0 "Breathing gas humidifier for use with oxygen therapy devices (bubbler humidifier)".
- Two billing item numbers are available in the product group for respiratory gas humidifiers for use with oxygen therapy devices, so-called bubbler humidifiers. Otherwise, there are no products listed in this product type itself and it is therefore dispensable.
Renaming:
- The product subgroups 14.24.09 / -.13 / -.20 / -.21 / -.22 / -.23 / -.24 and -.25 have been renamed. The renaming of the product type serves to clarify the language.
Proof of medical benefit:
- The option to provide evidence has been cancelled as MEDDEV 2.7 /1 Rev 4 essentially only applies under Directive EEC 93/42/EEC (MDD), which was replaced in 2017 by regulation (EU) 2017/745 on medical devices (MDR). In the past, these documents alone did not provide evidence of medical benefit.
- For affected product subgroups: To prove the medical benefit, case series or documented user observations are sufficient. Studies are not required.
Re-use:
- For affected product subgroups: Only a declaration is required as to whether reuse of the product by other insured persons is permitted and not that the product is in any case suitable for reuse by other insured persons.
Various quality requirements:
- For affected product subgroups: With the adaptation of the test specification to DIN EN ISO 80601-2-70:2021-06, the current state of medical technology is taken into account.
- For affected product subgroups: The requirements for the droplet spectrum are technical requirements and have therefore been moved from point IV. Medical benefits to point III.1 Indication/use-related quality requirements. At the same time, the test specification was adapted to the currently valid standard EN 13544-1:2009-12 and thus to the current state of medical technology. In accordance with a suggestion from SPECTARIS, the required particle spectrum was adapted in accordance with DIN EN ISO 27427:2020 5.4.2 f).
There are a number of other details in the editorial adaptation that we cannot go into here.
Our recommendation to all manufacturers affected:
Werfen Sie einen Blick auf Ihr Portfolio und prüfen Sie ob Maßnahmen erforderlich sind. Stellen Sie im Zweifel lieber eine Frage mehr an uns als eine zu wenig. Weitere Informationen finden Sie beim GKV-SV.
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