Product launch
Are you a manufacturer of a new product and want to put it on sale quickly and without problems? Are you an importer from third countries outside the EU and don't know what documentation and tests you need to launch a product on the EU market? Do you want to avoid problems during the inspection of control authorities? We will advise you how to do it!
What does placing a product on the EU market mean?
Product launch is defined as the first delivery of a product to the market as part of a business activity. This means handing over the product or transferring ownership of the product for the purpose of distribution, use or consumption on the European Union market.
What do I need to ensure before placing my product on the EU market? What documents are needed?
The products can be conceptually divided into two parts. Specified products that are subject to stricter criteria and conformity assessment procedures and products that are not specified and must meet only general safety principles.
Before a specified product can be placed on the EU market, it must be successfully assessed for compliance with the technical requirements of all directives and regulations that apply to it. This is proven by issuing a declaration of conformity and placing the CE mark on the product. The CE marking may only be attached to products for which this attachment is provided for in special Community harmonization legislation. For a successful conformity assessment, it is necessary to prepare technical documentation that contains information about the design of the product, its manufacturer and its functioning.
Technical documentation includes instructions for use, risk assessment, declaration of conformity, test results and other information related to the product.
Who is responsible for placing the product on the EU market?
The responsibility for placing a safe product on the European market, the completeness of the technical documentation and the proper assessment of the conformity of the product lies with the person established in the EU who manufactured the product, the authorized representative of the non-European manufacturer established in the EU or the importer of the product from non-EU countries.
By drawing up technical documentation and testing the product for compliance with EU directives and technical regulations, the responsible person can then declare compliance with these regulations and affix the CE mark. This guarantees that it is a safe product.
What legislative regulations of the Czech Republic apply to the launch of the product on the market?
Key regulations for placing products on the market include in particular Act No. 102/2001 Coll., on general product safety, Act No. 22/1997 Coll., on technical requirements for products and Act No. 90/2016 Coll., on assessment conformity of specified products when they are delivered to the market.
Act No. 102/2001 Coll.
It applies to products that are intended to be offered to consumers or for which consumer use can be reasonably foreseen, including items provided as part of a service.
Furthermore, in Sections 4 and 5, the Act contains a number of other obligations of manufacturers and distributors with regard to equipping the product with the necessary documentation, incl. warning of so-called residual risks (Section 4, paragraph 4), monitoring the safety of products already on the market, reporting the occurrence of dangerous products and cooperation with the supervisory authority.
Act No. 22/1997 Coll. and Act No. 90/2016 Coll.
These legislative regulations apply to so-called specified products. These are products that fall under some of the government regulations that were issued to implement this law, or under EU regulations adapted by this law. The material scope of these government regulations can be defined according to the type of product (e.g. toys, construction products, medical devices, low-voltage electrical equipment, machinery, radio and telecommunications equipment and others) or according to a certain property of the product (e.g. noise emission or electromagnetic compatibility ).
What happens if I, as a manufacturer, authorized representative or importer, do not comply with my obligations when placing a product on the EU market?
In the case of incorrectly prepared instructions for use, declaration of conformity or failure to submit documents for records to the supervisory authority, the responsible person commits an administrative offence. The administrative fine for this action is set at a maximum of 50 million CZK.
In the case of issuing a declaration of conformity without an assessment or knowingly operating machinery and equipment without technical documentation, the responsible person commits the intentional crime of public endangerment regulated by Criminal Code 40/2009 Coll. §272 paragraph 1 - shall be punished by imprisonment for three to eight years.
What is the role of Certifikujeme.to in this complex process?
For our clients, we provide testing of product safety and properties in accredited laboratories, check and process technical documentation and declarations of conformity so that all necessary steps are taken to bring the product to the market in compliance with the given regulations that apply to the given product.
We will also help you with the launch of your product on the EU market, whether it is toys, household appliances, machinery or other products. Contact us, we will be happy to answer your questions!