Group 11 - Non-categorised Medical Devices

This reimbursement group includes so-called non-categorised medical devices that cannot be included in any existing reimbursement group and can only be reimbursed if the Ministry of Health agrees to it.

Inclusion of a medical device in group 11 – uncategorised medical devices is possible with 50% reimbursement with the consent of the Ministry of Health, or with 100% reimbursement upon submission of a risk-sharing agreement with health insurance companies. A mandatory part of the risk-sharing agreement is a budget impact analysis, the establishment of an annual cost ceiling for such a medical device and the allocation of risks between health insurers and the notifier in case of exceeding the ceiling.

Link to the common methodology of health insurers – https://www.vzp.cz/poskytovatele/ciselniky/zdravotnicke-prostredky/spolecne-metodiky-vzp-cr-a-szp-cr-pro-nekategorizovane-zp

A link to the website of the Commission for Categorisation and Reimbursement Regulation of Medical Devices, where you can find the form Request for MoH approval for reimbursement of an uncategorised device and other necessary information on the application process – https://ppo.mzcr.cz/workGroup/121.