Conformity assessment

If so, then under Section 5 of Act No. 56/2018, you have the following obligations of the manufacturer of a designated product:

• before a designated product is placed on the market, ensure that the designated product is designed and manufactured in accordance with essential health and safety requirements;
• ensure conformity assessment in accordance with Section 22 of Act No. 56/2018 and the technical regulations governing the conformity assessment;
• draw up and make a declaration of conformity for the designated product, an EC declaration of conformity or EU declaration of conformity for the designated product in accordance with Section 23 of Act No. 56/2018 and the technical regulations governing the conformity assessment.

If, as an importer or distributor, you place a designated product on the market or make it available on the market under your name or trademark or you substantially modify a designated product already made available on the market, you are subject to the obligations of a manufacturer under Section 5 of Act No. 56/2018.