Law on technical requirements for products and conformity assessment

In the Official Gazette No. 274/22 of 20.12.2022, the Law on technical requirements for products and compliance assessment was published. This law regulates the way of prescribing the technical regulations that refer to the technical requirements that certain products or a group of products must fulfill when they are placed on the market and/or the technical requirements when using them for the intended purpose, the obligations of the economic operators involved in the chain of placing the products on the market, the procedures for assessing the compliance of the products with the prescribed technical requirements, the conditions that must be fulfilled by the compliance assessment bodies, the documents and signs for the compliance of the products, the principles and procedures for the recognition of foreign documents and signs of compliance, procedures for authorization and notification of compliance assessment bodies, monitoring the work of compliance assessment bodies, keeping records and reporting on technical regulations and compliance assessment bodies.

This law applies to products, or a group of products covered by technical regulations, except for products whose technical requirements are regulated by separate laws and regulations adopted on the basis of those laws.

The product placed on the market of the Republic of North Macedonia must satisfy the requirements for compliance, the requirements for documents and marks for compliance in accordance with the provisions of this law, as well as the technical requirements, the essential health and safety requirements, the requirements for the procedures for conformity, the requirements for the technical documentation and compliance documents, signs and labeling of a conforming product, in accordance with the provisions of the applicable technical regulations relating to that product.

The purpose of adopting the technical regulations is to determine the essential technical requirements that the product must meet and with them to ensure that the products are safe when they are placed on the market and put into use or used in accordance with their purpose, and especially for protection of the public interest, protection of life and health of people, animals and plants, protection of the environment and nature, protection of consumers and other users of the products and protection of property.

The technical regulations are adopted by the Minister of Economy, i.e. the minister in whose jurisdiction, determined by law, are matters related to the production, market, putting into use, use or utilization of the respective products.

The compliance assessment of products or a group of products that are covered by the harmonized technical regulations can only be performed by: accredited bodies consisting of a manufacturer and authorized conformity assessment bodies.

Any product that complies with the technical regulations of European harmonization legislation must be marked with the CE mark of conformity. The CE conformity mark is a letter mark ‘CE’ with the following form: . If the CE mark is reduced or enlarged, its proportions must be observed. The CE mark is affixed only by the manufacturer or his authorized representative. The CE mark is placed only on products for which its placement is determined by European harmonization legislation and may not be placed on any other product.

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