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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. Regulations 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 on all EU countries.

Estonian Medical Device Act regulates parts of the EU Regulation 2017/745 on Medical Devices that are left to decide for the EU member states (e.g. language requirements, distribution notification) and currently IVD directive 98/79/EC which is transposed into national law (which will be deleted once IVDR is implemented).