Market Surveillance Regulations
Regulation (EU) 2019/1020 of the European Parliament and of the Council on market surveillance (unamended version No. (EU) 2025/14, No. (EU) 2025/40) and the conformity of products with regulations, and amending Directive 2004/42/EC and Regulations (EC) No. 765/2008 and (EU) No. 305/2011. Amendment (EU) 2025/40 shall apply from August 12, 2026; Amendment (EU) 2025/14 shall apply from January 29, 2028. Furthermore, the term “Regulation on Conformity and Market Surveillance” is used in accordance with the “Consumer Product Safety and Market Surveillance Package ” and aims to eliminate the large number of legislative acts containing market surveillance rules and to create a single-pillar system that consolidates market surveillance rules into a single supervisory instrument. The “Regulation on Conformity and Market Surveillance” addresses certain shortcomings in the strategic objectives of Regulation (EC) No. 765/2008 —such as the growing number of non-compliant products, poor traceability of non-compliant products imported into the EU in the case of online sales, and insufficient border controls on products imported into the EU. The “Conformity and Surveillance Regulation” applies to all products covered by Union harmonization legislation and listed in Annex I. The “Regulation on Conformity and Market Surveillance” requires Member States to regularly (at least every four years, with the first report due on July 16, 2022) develop a national market surveillance strategy. It also establishes cooperation and mutual assistance procedures among Member States—evidence and findings from investigations in one Member State may be used in another Member State. To coordinate the enforcement of requirements set forth in EU harmonization regulations and to facilitate joint actions by Member States, Article 29 establishes a Union Network for Product Compliance , which will be operated by the European Commission. This system will be available to supervisory authorities in the Member States and the European Commission, and will inform the general public through the system’s public interface. In the case of products imported into the EU, a person established in the EU must be designated to be responsible for ensuring the product’s compliance with harmonization regulations. In accordance with Regulation (EU) 2018/1724, the EC will provide the “Your Europe” portal, where economic operators will be able to publish information via the online portal regarding voluntary measures taken in connection with risks posed by products they have placed on the market. As part of market surveillance and to ensure the reliability and consistency of testing throughout the Union, the Commission will designate Union testing laboratories for a specific product or a specific category/group of products, or for specific risks associated with a category/group of products. Union testing facilities must be accredited in accordance with Regulation (EC) No. 765/2008.
The procedures for designating Union testing laboratories are laid down in a Commission implementing act: Commission
Implementing Regulation (EU) No. 2022/1267 (Slovak version), which establishes procedures for the designation of Union testing laboratories for the purposes of market surveillance and verification of the conformity of products in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council (EU) 2019/1020, which will apply as of August 10, 2022. Commission Implementing Regulation (EU) 2022/1267 addresses the insufficient capacity for laboratory testing in the Union.
Conditions for the designation of Union testing facilities:
- Union
- testing facilities must be accredited in accordance with Regulation (EC) No. 765/2008;
- designated Union testing facilities provide their services only to market surveillance authorities, the network, the Commission
- ,
- and other governmental or intergovernmental bodies
- . The activities carried out by Union testing facilities within their scope of competence are: testing products at the request of market surveillance authorities, the Network, or the Commission; providing independent technical or scientific advice at the request of the Network; and developing new techniques and methods of analysis.
- Conditions for the designation of Union testing facilities (EU) 2026/1481
The European Commission has issued “Guidance for Economic Operators and Market Surveillance Authorities on the Practical Implementation of Article 4 of Regulation (EU) 2019/1020 on Market Surveillance and Product Compliance” (en, sk).
Article 4 concerns the obligations of economic operators in relation to products covered by certain Union harmonization legislation. This article applies to: construction products; personal protective equipment; gas-fired appliances; noise emissions from equipment intended for outdoor use into the surrounding environment; machinery; toys; eco-design of energy-related products; restrictions on the use of certain hazardous substances in electrical and electronic equipment; pyrotechnic articles; recreational craft and personal watercraft; simple pressure vessels; electromagnetic compatibility; non-automatic weighing instruments; measuring instruments; equipment and protective systems intended for use in potentially explosive atmospheres; electrical equipment designed for use within certain voltage limits; radio equipment; pressure equipment; unmanned systems (drones).Commission
Implementing Regulation (EU) 2021/1121, specifying the details regarding statistical data to be submitted by Member States concerning checks on products entering the Union market with regard to product safety and compliance with regulations (en, sk).
In the Czech Republic, the rules for market surveillance of specified products are set forth in Section 18 of Act No. 22/1997 Coll. and Act No. 90/2016 Coll. The market surveillance authority in the Czech Republic is the Czech Trade Inspection Authority (ČOI), which was established by Act No. 64/1986 Coll., on the Czech Trade Inspection Authority. This Act generally defines its supervisory competencies and powers with respect to the entities it supervises. This authority ensures that specified products are placed on the market and put into service only if they do not jeopardize legitimate interests—that is, the safety and health of persons or the environment—and thus comply with the requirements set forth in the relevant regulations .
In the Slovak Republic, Act No. 128/2002 Z. z. on State Control of the Internal Market in Matters of Consumer Protection (current version) (the amendment by Act No. 108/2024 Z. z. shall apply as of July 1, 2024).
Market surveillance is now newly regulated by Act No. 87/2023 Sb. (as amended by Act No. 387/2024 Coll.) on Product Market Surveillance and on Amendments to Certain Related Acts (the Product Market Surveillance Act). Act No. 87/2023 Coll. took effect on April 6, 2023. Act No. 87/2023 Coll. transposes into Czech law Regulation (EU) (EU) 2019/1020 into Czech legislation in the area of market surveillance and establishes powers and obligations for administrative surveillance authorities in the Czech Republic that had not previously been introduced into Czech legislation. Under Act No. 87/2023 Coll., market surveillance will apply in cases where the EU regulations listed in Annex I to Regulation (EU) 2019/1020 of the European Parliament and of the Council (EU) 2019/1020 do not contain specific, detailed provisions governing the supervision of particular products or categories of products.
The Ministry of Industry and Trade (MPO) is designated under Section 3 of Act No. 87/2023 Coll. as the central liaison office.
The MPO’s primary responsibility will be to coordinate cooperation among the supervisory authorities responsible for product market surveillance: the Czech Trade Inspection Authority, the Czech Mining Authority, the State Energy Inspectorate, the Office for Technical Standardization, Metrology, and State Testing, the Ministry of Transport, the Railway Authority, regional public health offices, the State Institute for Drug Control, the Central Agricultural Control and Testing Institute, the State Agricultural and Food Inspection Authority, the Institute for State Control of Veterinary Biopreparations and Medicines, the Czech Environmental Inspectorate, the Ministry of the Interior, and the Ministry of Defense.
These supervisory authorities are administrative bodies that exercised market surveillance over products even before the enactment of this Act.
The Annex to Act No. 87/2023 Coll. clearly defines the specific scope of authority of these supervisory authorities.
Market surveillance applies to products that fall within the harmonized scope, such as those covered by Act No. 22/1997 Coll. on technical requirements for products, Act No. 90/2016 Coll. on the conformity assessment of specified products when placed on the market, Act No. 206/2015 Coll. on pyrotechnic products, as well as other products. Act No. 87/2023 Coll. sets forth in Section 11 (Administrative Offenses) the amount of possible fines ranging from 100,000 CZK to 50,000,000 CZK.
Act No. 87/2023 Coll. amends Act No. 90/2016 Coll., Act No. 22/1997 Coll., Act No. 477/2001 Coll., Act No. 102/2001 Coll., Act No. 406/2000 Coll., and Act No. 156/1998 Coll.
The amendment to Act No. 387/2024 Coll.:
extends the scope of the Act on Market Surveillance of Products to include non-harmonized products,
the Hallmarking Office is added to the list of supervisory authorities,
a new power is granted to supervisory authorities to require online marketplace providers to remove specific content referring to the offer of a dangerous product from their online interface, block access to offers of dangerous products on their online platforms, or display an explicit warning to consumers about the
dangerous product (see Section 6).
Legislation is being prepared in the Slovak Republic—supervision in the area of consumer protection:
- Act on Supervision in the Field of Consumer Protection and on Amendments to Certain Acts
Market surveillance pursuant to Act No. 90/2016 Coll. on the Conformity Assessment of Specified Products is carried out by:
- Czech Trade Inspection Authority
- Czech Mining Authority
- Railway Authority
- other administrative authorities
Supervisory authorities conduct analyses or arrange for analyses to be conducted to verify compliance with the requirements of Act No. 90/2016 Coll. for specified products. If it is determined that a product does not comply with the requirements of Act No. 90/2016 Coll., the costs of the analysis are borne by the inspected entity. Supervisory authorities may require economic operators to eliminate the causes and deficiencies within a specified time limit, take the necessary measures, and immediately inform persons who could be endangered by the hazardous product of the danger. If a notified body participated in the conformity assessment of the product in question, the supervisory authority may require the notified body to review the certificate of conformity, and if it is found that the product does not comply with the relevant requirements, the supervisory authority may require the notified body to revoke the certificate issued to the economic operator. In the event of non-compliance with the technical requirements for a given product, the market surveillance authority may request from the notified body information and documents relating to the conformity assessment of that product, including the issued certificate, technical documentation, and test reports.
Market surveillance inspections may be conducted at various times throughout the product’s entire lifecycle after it has been placed on the market, such as during distribution, commissioning, or end use.
Protective Measures
The protective measures taken by market surveillance authorities include: prohibiting the supply of a product to the market; prohibiting the putting into service or use of a product by the manufacturer for its own purposes; withdrawing the product from the market or from distribution; destroying the product; or otherwise rendering the product unusable. These corrective measures are communicated to economic operators orally and are immediately recorded in writing. Protective measures may also be imposed following failure to comply with a request for corrective action in the case of so-called formal nonconformity, which consists of deficiencies in the conformity marking or in the documents certifying conformity. The inspection may also cover a CE marking that was affixed in violation of the law or was not affixed at all, a declaration of conformity that was not prepared in accordance with a government regulation, or the availability and completeness of technical documentation.
Products that pose a risk despite meeting the requirements
Act No. 90/2016 Coll. also addresses cases where a product poses a risk despite meeting all specified requirements; supervisory authorities may impose measures on the economic operator to ensure that the product in question no longer poses this risk or to withdraw the product from the market or from circulation. Corrective measures must also be taken in all Member States to which the product in question has been supplied. An appeal against this decision does not have suspensive effect.
Reporting Obligation
The supervisory authority shall inform the Ministry of Industry and Trade (MPO) of any measures taken regarding products posing a risk, even if such measures were taken voluntarily by the entity under inspection. Communication between the authorities of individual countries is important when a hazardous product is detected. This communication, which is handled by the MPO on behalf of the Czech Republic, takes place through the “RAPEX” rapid information exchange system.