Publication date: May 13, 2026
The CE marking was introduced as part of the harmonization of product marking processes within the EU. It is intended to replace all existing conformity markings. The marking itself indicates that the product meets the requirements of the applicable regulations. It is affixed to products intended for introduction into the EEA and Turkish markets, regardless of where they were manufactured.
Main regulations
The main acts that regulate the CE marking of products and the conformity testing that must accompany this process are: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (consolidated text: OJ L 218, 2008, p. 30, as amended) as well as Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (consolidated text: OJ L 218, 2008, p. 82).
CE marking
Although the mark is generally believed to be an abbreviation of the French expression “Conformité Européenne”, no EU legal act provides such an expansion of this abbreviation.
The appearance and method of affixing the CE marking are specified in Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008, stating that it consists of the initials “CE” presented in the form specified in the regulation. Unless other regulations specify a different height, it shall be at least 5 mm. In all cases, the proportions of the mark must be maintained. It must be affixed so that it is visible, legible, and indelible from the product. The CE marking is followed by the identification number of the notified body, if it was involved in the production control phase. If the CE marking cannot be affixed to the product, it should be affixed to the packaging or accompanying documentation.
Union harmonisation legislation requires the manufacturer to draw up and sign an EU declaration of conformity before placing the product on the market.
The manufacturer or its authorized representative established within the EU is required to draw up and sign an EU declaration of conformity as part of the conformity assessment procedure provided for in Union harmonisation legislation. The EU declaration of conformity is a document stating that the product complies with all relevant requirements of the applicable legislation.
By drawing up and signing the EU declaration of conformity, the manufacturer takes responsibility for the product’s compliance with the regulations.
The EU declaration of conformity must be continuously updated and kept for ten years from the date the product is placed on the market, unless a different period is specified by law.
According to the model declaration in Decision No 768/2008/EC of 9 July 2008, the declaration should include:
1. unique product identifier,
2. name and address of the manufacturer or authorized representative issuing the declaration,
3. a statement that the declaration is issued under the sole responsibility of the manufacturer,
4. Subject of the declaration (product identifier enabling the reconstruction of its history. Where appropriate, it may include a photo),
5. all relevant provisions of Union harmonisation legislation that the product must comply with, referenced standards or other technical specifications (such as national standards and technical specifications) in a precise, complete and clearly defined manner,
6. Where applicable, name and number of the notified body that issued the certificate,
7. Additional information,
8. Date of issue of the declaration, signature and position or equivalent designation of the authorized person,
Modules
The mark itself is intended to indicate that the product meets the requirements specified in the law. The product is marked with it by the manufacturer, either independently or with the participation of a national authority (conformity assessment body, notified body). For this purpose, the manufacturer assesses conformity using modules (described in the Commission Notice Blue Guide – Implementation of EU product regulations 2022 (i.e. OJ EU C. of 2022 No. 247, p. 1) and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008). The modules refer to both the design and production phases. Conformity assessments can be performed using one or two modules. Assessment modules can refer to one of the phases (e.g. only to the production phase), or to both. If a module refers to only one phase, the assessment consists of two modules, while if it refers to both phases, the assessment consists of one.
There are eight modules in total, but with the addition of variants, their number increases to 16 (A, A1, A2, B, C, C1, C2, D, D1, E, E1, F, F1, G, H, H1). Each subsequent module contains further requirements, along with increasing risks posed by the product. In the “least demanding” module, A, the manufacturer only prepares technical documentation and takes all necessary measures to ensure the production process ensures compliance of manufactured products with the technical documentation, and then affixes the marking to the product. In the highest module, H1, the manufacturer must have an approved quality assurance system (approved by a notified body) for design, production, and inspection and testing of finished products. It is also subject to supervision by a notified body. The notified body may also pay unannounced visits to the manufacturer, during which it may conduct or commission product tests.
Entities involved in conformity assessment
At the outset, it is worth noting that regardless of whether a notified body is involved in the conformity assessment procedure or not, the conformity assessment is the manufacturer’s responsibility, and the declaration of conformity is made under his sole responsibility.
There are three possibilities for the involvement of other entities in the conformity assessment procedure:
– No involvement of external entities. In such a case (and this usually applies to products that the legislator has deemed not to pose such a risk that the manufacturer cannot be entrusted with the independent conformity assessment), the manufacturer prepares the declaration itself (along with the appropriate tests and technical documentation), and conducts the tests, inspections, and guarantees compliance during production.
– Conformity assessment is carried out using an accredited in-house body, i.e., a part of the manufacturer. However, this body cannot perform any tasks other than conformity assessment. It must be independent of commercial, design, and manufacturing entities and must possess the same level of technical competence and impartiality as external assessment bodies. They may conduct assessments within the scope of modules A1, A2, C1, or C2.
– Conducting the assessment with the involvement of an external entity. If the legislator deems such intervention necessary, an external conformity assessment body will participate in the conformity assessment. This body must be impartial and fully independent of the organization or the product it assesses. It must not engage in any activities that might compromise its independence, and it must not have user or other interests in the product being assessed.
Member States are responsible for designating conformity assessment bodies. They must designate bodies (within their jurisdiction) that have the appropriate competence to assess product conformity.
Even though in-house bodies cannot be notified (i.e. they cannot be external conformity assessment bodies), they must demonstrate at least the same level of technical competence as external bodies through accreditation.
Notified bodies
Conformity assessment bodies (referred to as notified bodies in EU legislation) are entities designated by Member States. Appointed notified bodies must then be notified to the European Commission.
They play roles in the conformity assessment process, responsible for activities such as calibration, testing, certification, and inspection. To qualify as a notified body, a body must be a legal entity established in a Member State, but it may operate or employ personnel outside a Member State or even outside the EU.
The bodies must be accredited, which means that the relevant national accreditation body must confirm that the conformity assessment body meets the requirements set by the harmonised standards and any additional requirements for carrying out specific conformity assessment tasks.
Member States may designate a maximum of one national accreditation body. However, they may choose not to designate such a body and instead have accreditation performed in their territory by an accreditation body from another Member State. In both cases (designation or non-designation), Member States are required to notify the European Commission.
Notified bodies are subject to oversight by national notifying authorities and must keep them informed about their activities (including, for example, availability of resources, performance of conformity assessments, subcontracting of work, and conflicts of interest). They must provide, directly or through another body (e.g., a national accreditation body), all information concerning the proper implementation of the conditions under which they were notified, upon request, both to their notifying authorities and to the Commission.
The notifying authority is responsible for the activities of notified bodies. It must remain capable of ensuring monitoring. If such monitoring is not possible, the notifying authority must withdraw or limit the scope of the notification to the extent necessary.
It’s also worth mentioning that the independence requirement (which also means that notified bodies “are and must remain” third parties independent of their clients) does not mean that only state bodies can become notified bodies. On the contrary, both state and private entities can apply for this status, provided their independence, impartiality, and reliability are guaranteed, and they constitute independent legal entities with appropriate rights and obligations.
Product labeling requirement
The CE marking is not required for every product, only for those for which legislation requires it. Currently, these include toys, electrical products, machinery, personal protective equipment, and cranes. It is prohibited to affix the CE marking to products that are not covered by the CE marking regulations.
Changes in the law
There have been no significant recent changes to the legislation governing the CE marking. However, sector-specific regulations necessarily influence the use of the mark. Such as Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ EU L 2024, item 2847, as amended) or Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904 and repealing Directive 94/62/EC (OJ EU L 2025, item item 40) and acts requiring CE marking of products such as Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) Text with EEA relevance (OJ L 1689, 2024).
In its Annex I, Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 lists Union harmonisation legislation.
In summary, the purpose of the CE marking is to signal that a product meets the requirements of the applicable regulations. It is affixed to the product by the manufacturer, either independently or with the involvement of accredited internal bodies or a notified body, following the conformity assessment module(s) appropriate for the level of risk posed by the product, and under their own responsibility.
CE Marking – what really stands behind those two letters?
CE marking is more than just a symbol on a product – it’s a legal declaration that the product complies with all applicable EU requirements and can be placed on the EEA and Turkish markets, regardless of where it was manufactured.
It is the result of a structured conformity assessment process defined in EU harmonisation legislation (including Regulation (EC) No 765/2008 and Decision No 768/2008/EC). Depending on the level of risk, this process may involve the manufacturer alone, internal accredited bodies, or independent notified bodies.
By affixing the CE mark, the manufacturer takes full responsibility for product compliance. In parallel, an EU Declaration of Conformity must be issued, maintained, and kept up to date, confirming that all relevant legal requirements have been met.
The system is built on risk-based modules – from basic self-assessment to highly controlled certification schemes involving external oversight. This ensures proportional control while maintaining product safety and market access across the EU.
In short: CE marking is not a quality label – it is a regulatory passport for products entering the European market.
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