Attentiveness and care is required when applying for changes in the medical aids directory.
Anyone who wants or needs to change or add to an existing entry in the German Medical Technical Aids Register. should do this with just as much care as the application for listing in the List of Medical Aids itself.
What counts as a change in the medical aids register?
A change in the medical aids directory can vary in many ways. Often it is nothing significant, for example, just the color in which your product is available. If this color was listed at the beginning, I may have an interest in removing the color variant that is no longer available from the list of medical aids.
This is not a big deal in itself, but the details of the revised fitting sheets, the revised instructions for use, the labeling, the packaging, the accessories, etc. must also be checked for consistency.
Have the intended purpose or the instructions for use been revised over the years or in the course of the changeover to MDR-Requirements?
Changing the intended purpose or the indications also constitutes a product change, which I am not focusing on in the color change request. The GKV Spitzenverband examines the change request and the product-related documents as a whole.It is not uncommon for the value promise of Home Care products to change slightly over the years.
In this case, check the conformity of your statements with all requirements for the product type. The same must be taken into account if a supposedly identical model is to be added to your existing listing item.
Did you remember to prove in your change request that the products are not only technically identical, but that the performance promises are (or remain) the same?d?
In short, treat a change request like a new request in the medical aids directory. This will save you considerable time and will not jeopardize the continuity of your existing HiMi item number/aid number.
Contact us if you are planning to make changes to your existing medical aid entries and need support with the implementation. We will be happy to help you!
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