The proposed amendment aims to expand patient access to medical devices on prescription, taking into account both new items and adjusting limits to market realities. The proposed amendment introduces changes in response to the demands of patients, doctors and patient organizations. The aim of these proposals is to increase the availability of medical devices and to make the current regulations more specific, thereby eliminating interpretation problems.
The new wording for Paragraph 2(2) of the regulation is intended to organize the regulations regarding the authority of physicians during and after specialization to issue orders for medical devices.
The annex to the regulation, due to the size and scope of the changes, as well as the need to take into account the possibility of introducing new products within certain categories, received a completely new shape ...
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