Product groups 23 ‘Orthoses’, 33 ‘Toilet aids’ and 08 ‘Insoles’ were updated by the GKV-SV.
New developments in PG 23 ‘Orthoses’
The German National Association of Statutory Health Insurance Funds (GKV Spitzenverband) has updated product group 23, ‘Orthoses’. We have summarised the key changes to the definition of this product group for you here:
- Sharpening the purpose of individual types of orthoses
- More detailed requirements for functionality and accuracy of fit
- Clarifications regarding the instructions for use (completeness, comprehensibility)
- Greater focus on instructing insured persons as part of service provision
The update was announced by the GKV-SV on 2 December 2025. The full text of the update can be found here.
New features in PG 33 ‘Toilet aids’
The main changes for product group 33 concern:
- Specifications regarding load capacity – concerning minimum load capacity, fixation and stability
- Extension of requirements for product labelling and technical data
- Higher accessibility requirements for instructions for use
- Clarification of requirements for service, delivery and warranty services
The update was announced by the GKV-SV on 11 December 2025. The full text of the update can be found here.
New features in PG 08 ‘Deposits’
The first update published by the GKV-SV in the new year concerns product group 08, ‘Insoles’. The main changes include:
- Systematic clarification of deposit types and manufacturing logic
- Uniform and, in some cases, stricter quality requirements – final adaptation to EU MDR standards
- Specified functional and biomechanical requirements – Greater distinction between bedding, support and corrective functions
- Extended requirements for product information and instructions for use – particularly with regard to the accessibility of accompanying product documents
- Precise structuring of billing items and options
The updated product group 08 ‘Insoles’ was announced by the GKV-SV on 14 January 2026. The complete update text here.
Our Recommendation: Active Monitoring and Informed Reaction
If you are a manufacturer or importer selling products that belong to one of the two revised product groups, we recommend that you familiarise yourself with the amended requirements for orthoses and toilet aids, check the products concerned and retrofit them if necessary.
BEO BERLIN is at your Side – Professional and Pragmatic
As an experienced expert in regulatory affairs and specifically as an HMV-REP, BEO BERLIN works in partnership with manufacturers and suppliers throughout the entire adaptation process – from reviewing your portfolio to adapting products after the update has been completed.
With professionalism, pragmatism and our eyes on the essential, BEO BERLIN is at your side.
Write us – we are here to help!
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