For proper introduction to the market, the manufacturer is obliged to prepare technical documentation required by government directives for evaluation of conformity of the product with respective requirements and for risk assessment.
Technical documentation, together with the EU Declaration of Conformity must be submitted to the respective national authorities on request. In the Czech Rep. these authorities are e.g.:
The Electrotechnical Testing Institute offers a review of the correctness of documentation with regard to the requirements of relevant government directives. This service is not offered for medical devices.
Ing. Vlastislav Filgas
Head of Trade Department
