law on technical requirements for products and conformity assessment

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Article 13When the technical regulation specifies that conformity assessment is conducted by the appointedconformity assessment body (hereinafter referred to as: appointed body), decision on itsappointment shall be issued by the competent minister, in accordance with the <strong>law</strong> governinggeneral administrative procedure.The competent minister shall issue a decision on appointment, provided the conformity assessmentbody which submitted an application for appointment meets the requirements from the technicalregulation in the context of Article 12 of this Law.When assessing the compliance with the prescribed requirements, the competent minister shall alsotake into account the act on grant of accreditation which the conformity assessment body hasobtained within the accreditation procedure.The decision referred to in paragraph 1 of this Article shall be final.Article 14The appointed body referred to in Article 13 paragraph 1 of this Law shall, based on the contractwith manufacturer, conduct conformity assessment in accordance with the procedures specified inthe technical regulation.Prior to the issuance of document of conformity, the appointed body shall request the manufacturerthat failed to meet the prescribed requirements to undertake appropriate corrective measures.Where the appointed body, during the control of conformity, after the document has been issued,finds that a product no longer meets the prescribed requirements, it shall request the manufacturerto undertake appropriate corrective measures and, if necessary, it may temporarily or permanentlyseize the document of conformity or limit validity of such document.The appointed body may, with the consent of the manufacturer, delegate certain tasks with regardto conformity assessment to the subcontractor, provided the subcontractor meets the requirementsfrom the same technical regulation as the appointed body.The appointed body may delegate to the subcontractor only those tasks for which such body hasbeen appointed. The appointed body shall retain the responsibility for the tasks delegated to thesubcontractor.The manner of conducting conformity assessment referred to in paragraph 1 of this Article shall begoverned by the regulation adopted by the Government.Article 15The appointed body shall notify the competent minister of:1) refusal to issue, restriction, temporary or permanent seizure of the document ofconformity;2) any changes in circumstances from the decision on its appointment that may affect thescope and requirements of the appointment;3) a request of the competent inspector related to the conformity assessment;4) delegation of tasks to the subcontractor referred to in Article 14 paragraph 4 of thisLaw;6
5) conducted conformity assessment within the scope of its appointment, in the country orabroad;6) other conformity assessment related activities.The notices referred to in paragraph 1 items 5 and 6 of this Article shall be submitted upon requestof the competent ministry.Article 16If the competent minister finds that the appointed body no longer meets the prescribedrequirements or no longer performs its duties, it shall issue a decision on withdrawal of theapproval for conducting conformity assessment, in accordance with the <strong>law</strong> governing generaladministrative procedure.Before issuing the decision referred to in paragraph 1 of this Article, the competent minister may,taking into account the significance of deficiencies with respect to compliance with therequirements or performance of duties, warn the appointed body in writing about the deficiencieswith respect to the compliance with requirements or performance of duties, and set the deadline forelimination of such deficiencies, which may not exceed 60 days.The decision referred to in paragraph 1 of this Article shall be final.In the event of issuance of the decision on withdrawal of the approval referred to in paragraph 1 ofthis Article or in the event that the appointed body ceases operations, the competent minister shallinstruct such body to transfer the conformity assessment related documentation within the specifiedperiod to another appointed body, as chosen by the manufacturer, namely to allow access to suchdocumentation to the competent authorities.Conformity Assessment Conducted by the State Administration AuthorityArticle 17Where the technical regulation prescribes that conformity assessment is conducted by the stateadministration authority, the competent state administration authority shall, at the request of themanufacturer, conduct conformity assessment in accordance with the procedures prescribed bysuch regulation.Before issuing a document of conformity, the state administration authority shall order themanufacturer that failed to meet the prescribed requirements to undertake appropriate correctivemeasures.If the state administration authority, during the control of conformity, after issuing the document ofconformity, finds that the product no longer meets the prescribed requirements, it shall instruct themanufacturer to undertake appropriate corrective measures and, if necessary, issue a decisionseizing the document of conformity, temporarily or permanently, or restricting the validity of suchdocument.The decision referred to in paragraph 3 of this Article shall be final.The costs of conformity assessment referred to in paragraph 1 of this Article shall be borne by themanufacturer.7
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law on technical requirements for products and conformity assessment

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