PG 33 "Toilet aids" is being updated in the list of medical aids. On June 11th, 2024, the GKV-Spitzenverband wrote to manufacturers and authorised representatives who have listed one or more products in this product group.
PG 33 "Toilet aids"
- The National Association of Statutory Health Insurance Funds in Germany (GKV-Spitzenverband) states that PG 33 is being updated and manufacturers must now submit a statement and documentation.
- In order to keep your HiMI-number, you will need to provide the following information:
- Declaration as to whether the aid is still being manufactured
- valid declaration of conformity
- current instructions for use
Your answer must be submitted by early September 2024. If you have not responded by then, your HiMi number may be deleted. The documents submitted will be reviewed by the GKV-Spitzenverband. If there are any deviations from the current requirements of the EU MDR and SGB V (Social legislation book 5), you will receive another consultation letter at a later date.
We recommend that you do not put off responding, otherwise your products may be deleted from the list of medical aids. In this case, it should be easy for you to comment on fulfilment of the requirements. If you are unsure, please do not hesitate to contact us.
Our customers who have appointed us as HMV representatives do not need to do anything initially. We will take care of maintaining your HiMI-number for you.
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