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Legislative framework for medical devices

The current Estonian Medical Devices Act entered into force on 1. December 2004 (last amendment entered into force on 1. June 2016). Several governmental regulations and regulations of the Minister of Social Affairs have also been published to support the Act. These regulations stipulate and/or elaborate provisions of the Medical Devices Act and related European Directives, as follows:

The Act and its associated regulations control the manufacturing, marketing, advertising and professional use of medical devices. They also specify rules for market supervision, and regulate the liability of interested parties for non-conformities, violations and perpetrations. The Act also contains references to other applicable regulations. As an example, the Product Conformity Act is referred to as the one regulating some responsibilities of manufacturers, distributors, certification and market supervisory authorities.

All the amendments to the European medical devise Directives, including 2007/47/EC, are transposed into Estonian legislation. At the moment amended versions are available only in Estonian.