Legislative framework for medical devices
Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) are directly applicable at national level. These are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety for all EU countries.
Estonian Medical Devices Act sets out additional national requirements that are to be met in the field of medical devices and that are not regulated by the MDR or IVDR including language requirements, distribution notification etc. The current Medical Devices Act is in force since 01.01.2023.