Medical Devices
Medical Devices Act (RT I 2004, 75, 520)
The new medical devices act entered into force on 1 December 2004.
Before its enactment the area was regulated by several acts (e.g Public Health Act), which have been repealed partially by the new act. The text of the new act is currently available in Estonian language; within couple of months the text in English will be published also on the website of Estonian State Agency of Medicines. Several new governmental regulations and regulations of Minister of Social Affairs based on the new act have been also published in Estonian.
These regulations stipulate and/or elaborate provisions of medical devices
act and related EU directives, as follows:
- regulation No. 118:2004 of MoSA: notifications of placing of medical devices on the market and notifications of sufficient changes on the devices
- regulation No. 119:2004: notifications about the hazards and notification forms
- governmental regulation No. 343:2004: classification rules for medical devices
- governmental regulation No. 353:2004: Essential requirements to design, manufacturing and packaging of medical devices and accompanying information
- governmental regulation No. 354:2004: Regulations on conformity assessment procedures for medical devices
The new act and related regulations regulate manufacturing, marketing, advertising of medical devices and give rules for market supervision, also regulate liability of market actors for non-conformities, violences and perpetrations.
In the act, for a number of issues the reference to other applicable regulations are involved. As an example, product safety act is referred as the one regulating some responsibilities of the manufacturers, distributors, and certification and market surveillance bodies.
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