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:
- Regulation No 10: 2011 of the Minister of Social Affairs on notifications of placing of medical devices on the market and putting into service or starting distribution in Estonia market and notifications of sufficient changes on the devices (in Estonian)
- Governmental Regulation No 343: 2004 on classification rules for medical devices (in Estonian)
- Governmental Regulation No 354: 2004 on the regulations for the Conformity Assessment Procedures for medical devices (in Estonian)
- Regulation No 86: 2010 of the Minister of Social Affairs on the conditions and procedures for the clinical investigation of medical devices (in Estonian)
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.