What's the deal with "dispensing" medical devices in doctors' offices?

Recently, the topic of dispensing medical devices directly in doctors' offices has been resonating quite strongly among physicians. Most of them associate it with the date of January 1, 2026, when electronic prescription of medical devices will become mandatory. In this context, however, it should be noted that ePoukaz itself does not prevent the legal dispensing of medical devices at all. Nevertheless, it is true that it significantly contributes to the possible detection of cases where medical devices are dispensed to patients illegally. That said, this practice was problematic even before, and a number of changes are coming as part of the regulation that will likely eradicate it completely soon.

First and foremost, it should be noted that medical devices may be stored, used, and in some cases also dispensed to patients in doctors' offices. However, there are rules governing these activities. As far as the dispensing itself is concerned, in addition to pharmacies and medical device dispensaries, many types of devices can also be dispensed by so-called contractual dispensers who have special dispensing contracts with health insurance companies. Contractual dispensers are commonly phoniatrists, for example, who legally dispense hearing aids to patients in their offices.

Another case of legal provision of a medical device to a patient directly in a doctor's office is its use as part of treatment under the ZUM (Separately Billed Materials) regime or directly consumed material that is included in the related medical service.

The last illustrative example is a situation where a prescribed medical device is delivered by mail, with the patient choosing their doctor's office as the delivery address.

What is causing widespread anxiety is the fact that everyone is well aware that each of the above scenarios is subject to certain legal rules, which, however, are clearly not being followed in practice in numerous medical offices. For example, a special contract with a health insurance company must be entered in order to dispense medical devices in a doctor's office. Before dispensing or using a medical device in a doctor's office, it is necessary to comply with the rules of good storage practice, including temperature measurement and record keeping. The use of Class IIb or III medical devices must be recorded in the patient's medical records.

It is not possible to issue a medical device that the dispenser has not purchased

Further difficulties arise in the case of the aforementioned mail order dispensing. This is certainly possible, including delivery to a doctor's office, but first a specific product must be prescribed to the particular patient, and only then can such a product be shipped. Similarly, it is not possible for the dispenser to first dispense a medical device that is still owned by the distributor at that time and only then purchase it for accounting purposes.

A doctor should definitely not promote a specific dispenser and at the same time must not restrict the patient's right to freely choose a dispenser. Financial motivation for doctors is completely beyond the bounds of ethics and the law.

Author: Jakub Král