The year 2021 was a turning point for the regulation of medical devices, both in terms of national legislation and at the level of the European Union. Despite the annual postponement, the mandatory applicability of the MDR (EU Regulation 2017/745) occurred on 26 May 2021, and the new Medical Devices Act (Act No. 89/2021 Coll.) Entered into force on the same day, as did the regulation of advertising for medical devices and diagnostic medical devices (part of the accompanying amending Act No. 90/2021 Coll.). The changes are fundamental, but the legislative storm does not end there. From 1 January 2022, there were also changes in the reimbursement of medical devices prescribed on the voucher, as well as partial changes in the area of VAT for certain groups of medical devices as a result of the adoption of Act No. 371/2021 Coll. (Extensive amendment to the Public Health Insurance Act, which also amended some related regulations, including the VAT Act). In principle, we have exhausted the most important changes that have already taken place, however, we expect many more innovations during this year.
A new price regulation of the Ministry of Health should be issued in the course of January, which responds to the result of the tense autumn discussion between representatives of medical device suppliers, health insurance companies and the Ministry of Health. The conclusion is that a year-on-year increase in the price of regulated medical devices (voucher-paid medical devices, ZUM and PMAT) should be allowed to increase by up to 4% above the highest prices demonstrably applied in 2021. The current price limit is 3%. The Ministry of Health's announcement in the Collection of Laws confirming the full functionality of the ePokaz electronic prescribing system for medical devices is also eagerly awaited. According to the latest available information from the Ministry of Health, its sharp operation should start as early as March 1, 2022, however, a complication could be the fact that the Ministry has not yet issued a decree setting out the requirements for an electronic voucher for medical devices, the existence of which is a necessary condition. for the legal functioning of the whole system.
At EU level, an accelerated regulation should be adopted at the turn of January and February to adjust the transitional period contained in the IVDR (EU Regulation 2017/746) in such a way as to phase out the mandatory implementation of the IVDR into several waves depending on the IVD risk classes. However, it must not be forgotten that IVDR will be mandatory for new IVD and non-sterile Class A IVD from 26 May 2022. The new domestic law on medical devices and IVD, which should return under one roof agenda of general medical devices on the one hand and IVD on the other. The annual deviation in the mandatory applicability of the MDR and IVDR is provisionally resolved by a combination of Act No. 89/2021 Coll. for general medical devices and the ongoing renamed Act No. 268/2014 Coll., on IVD. As of May 26, 2022, both areas should already have new legislation in common. A positive side effect of this change should be the possibility of electronic prescription also in the case of IVD (eg blood glucose strips). Here, however, it is necessary to point out the major delays in the legislative process. The common law has not yet been approved at the government level, and the next phase of negotiations in the Chamber of Deputies and the Senate normally takes half a year. The Czech Republic is thus in danger of delaying the adaptation of IVDR, which would cause considerable difficulties for IVD suppliers and regulators, especially the State Institute for Drug Control.
Author: Jakub Král
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