ECONOMIC OPERATORS REGISTERED BEFORE THE REGULATION (EU) 2017/745 ON MEDICAL DEVICES (MDR – BEFORE 26.05.2021) AND BEFORE THE REGULATION (EU) 2017/746 ON IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDR – BEFORE 26.05.2022)
If an economic operator was already registered before the Regulation (EU) 2017/745 on medical devices (MDR) became applicable, i.e. before 26 may 2021 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), re-registration of such economic operators in registers of activities in the field of medical devices is carried out in a voluntary manner, however, it is recommended, as the JAZMP and the Ministry of Health are drafting a new Medical Devices Act. Once adopted, re-registration for all economic operators will be mandatory.
Re-registration in accordance with the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), can be carried out by clicking here.