In May 2017, two new EU regulations were announced - Regulation 2017/745 / EU on medical devices (MDR) and 2017/746 / EU on in vitro diagnostic medical devices (IVDR). The first one has been applied to the greatest extent since May 26, 2021. The second one is scheduled to start on May 26, 2022.
Work is still underway on the government bill on medical devices, which is to adapt the national law to EU regulations. The work was extended due to the postponement of the application of the above-mentioned regulations and the COVID-19 pandemic.
On January 19 and 27, 2022, subsequent meetings of the extraordinary subcommittee for consideration of the government project were held, during which significant amendments to the project were voted on. We describe these changes in a summary that you can download below.
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