The turn of the year is always accompanied by some kind of taking stock of what has happened in the past year. As far as the medical devices segment is concerned, there was really not little of it. This change can be perceived as a certain pulling of the rescue brake from the point of view of medical device manufacturers and notified bodies themselves. Otherwise, there is an acute risk that a large part of the medical devices that have been successfully used in the EU market for years will disappear in the near future. The other side of the same coin is the prolongation of the period during which all research, development and innovation of medical devices in the EU is largely suspended, as another condition of legacy device status is a strict prohibition on making significant changes. At the same time, the situation is dramatically complicated for healthcare providers who will have to live with medical devices for another 5 years or so in two very different legal regimes.
On a national level, we have all started to familiarise ourselves with the new Act 375/2022 Coll, on medical devices and IVDs, which came into force de facto at Christmas 2022 and which we will probably be operating with for quite some time. As of March, the VZP has introduced new rules for the inclusion of ZUM in its codebook. During the autumn, the issue of the maximum year-on-year price increase of regulated medical devices for 2024 was resolved. The Ministry finally set a limit of 5.5% against the highest price actually applied in 2023. SÚKL announced that it has already completed the preparation of the Medical Devices Information System, which is to replace, among others, the outdated RZPRO. The new system is undergoing internal testing and is expected to start live operation in March 2024. At the very end of the year, the consolidation package was adopted, which, among other things, adjusted VAT on medical devices. The main change is that all medical devices that are intended by the manufacturer for single use fall under the new reduced rate of 12%.
As a Christmas present, the Czech Metrology Institute was appointed as a notified body under the MDR. The Czech Republic has thus already the second organisation authorised to certify new medical devices after ITC in Zlín.
Author: Jakub Král