Let’s Get Started On The Shoes!
Anyone in Germany who sells shoes listed in the German Medical Technical Aids Register (Hilfsmittelverzeichnis – HMV) may already have heard about this: on 29 April 2026, the National Association of GKV announced the update to PG 37 – Shoes – as we reported.
Details – And Plenty Of Them!
We don’t want to bore you with the nitty-gritty. Most of the changes relate to the nature and scope of specific quality requirements for specific sub-groups within PG 31.
For sub-group 31.03.03, photographic product documentation must be submitted in the form of a PDF file, showing the product in its entirety and from all relevant angles (at least external views from several perspectives, as well as relevant detailed views).
The updated version, which runs to around one hundred pages, and the consultation process between the GKV and industry interest groups – which spans over four hundred pages – contain numerous new formulations, minor additions and deletions.
The best way to check whether your product meets the requirements of the updated product group is therefore to check individual products directly: rather than looking for a list of all the changes, compare the products you wish to re-register against the updated requirements – or get in touch with your trusted medical device consultants!
The Bigger Trend
Despite the complexity of the update, the GKV approach is clearly set out in the documents: harmonisation with the European standard, as laid down by the EU MDR and the guidelines of the MDCG , is set to continue.
This is good news for manufacturers and for healthcare provision across the EU. After all, where requirements still diverge, the workload increases. However, if the regulatory requirements for the EU-issued CE marking and for inclusion on the German list of aids are identical, this means less work overall.
Illustration: Gradual harmonisation reduces the regulatory burden.
To be included in the German list of aids, medical devices must i) meet the requirements of the EU MDR (blue circle) AND ii) comply with the requirements of the list of aids (i.e. the product groups) (green circle). The regulatory workload is represented here by the total area of both circles. If the requirements diverge significantly, the regulatory workload increases (Figure 1); if they coincide, the regulatory effort is minimal (Figure 3).
Why Should Manufacturers Review Their Product Range?
Some time after the update has been published – particularly if it is as comprehensive as that of PG 31 – the GKV checks that the products comply with the new requirements. A ‘manufacturer enquiry’ is carried out!
If non-compliance is identified in this process, this may result in the product being removed from the list of aids.
It is therefore worth reviewing your own portfolio now to be on the safe side.
For several weeks now, our HMV experts have been working intensively on the new requirements for footwear seeking a listing on HMV.
Please get in touch with us and arrange for your products to be assessed by BEO BERLIN – to ensure successful reimbursement for your products.
Please feel free to contact us.
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