The CE marking is mandatory for products falling under one or more European directives that explicitly require its application. Products not covered by any of these directives are prohibited from bearing the CE marking. The CE marking affords products the privilege of unrestricted circulation throughout the entirety of the European Union’s territory.
To secure and display the CE marking on a product, the manufacturer must conduct assessments and tests to confirm the product’s conformity with essential requirements, particularly those pertaining to health and safety, as delineated in the pertinent directive(s).
It is worth to note that the CE marking does not constitute a certification mark, nor does it denote the geographical origin of the product. It is, in fact, a mandatory and regulatory mark, symbolizing the manufacturer’s overt commitment to compliance with European legislation.
Determining whether a product, whether domestically produced in France or imported, falls within the ambit of the CE marking requirement necessitates reference to the provisions of technical harmonization directives or national enactments that transpose them. These texts define the scope of applicable products and, if applicable, those products exempted.
Approximately twenty technical harmonization directives prescribe the use of the CE marking, encompassing diverse product categories. Only products subject to these directives are obliged to bear the CE marking.
Below is an enumeration of regulatory texts (directives and regulations) stipulating the requirement for the CE marking:
- Regulations under the New Approach that incorporate the CE marking
- Conformity assessment procedure
Conformity assessment of products typically unfolds across two stages, pertaining to the product’s design phase and its manufacturing phase.
Eight classifications of conformity assessment procedures (or modules) are applicable contingent on the nature of the products:
- Internal production control
- EC type-examination
- Compliance to type
- Production quality inssurance
- Product quality inssurance
- Verification of product
- Unit verification
- Full quality inssurance
It is incumbent upon the relevant legislation to determine which modules are applicable to a particular product.
CE Marking of Conformity:
- Adheres to a distinctive graphical design featuring the CE symbol and, in instances involving a notified body’s participation in the product’s production control phase, the identification number of said body.
- Is affixed to the product itself, its packaging, or accompanying documentation.
- Grants the associated product the liberty to enter the European market, move freely within, and be utilized therein.
Should an industrial product fall under multiple directives necessitating the CE marking, the presence of this marking signifies conformity with all applicable directives. Nevertheless, only one marking is affixed to the product.
Additional markings, including those signifying compliance with national or European standards, may be applied to products, provided they do not engender confusion with the CE marking.
Declaration of Conformity
It is imperative to attest to the product’s compliance with the essential safety requisites stipulated in the pertinent technical harmonization legislation. This attestation conventionally materializes through a declaration and a technical dossier.
The CE Statement of Conformity
Irrespective of their global location, the manufacturer (or their appointed representative within the European Economic Area) is mandated to draft a CE Declaration of Conformity, even in cases involving the engagement of a third-party conformity assessment entity. This document serves as an affirmation that the product aligns with the indispensable health and safety requirements outlined in the applicable regulations, thereby entailing the manufacturer’s accountability. Typically, the information encapsulated within this document encompasses:
- The manufacturer’s name and address or that of the authorized representative
- A comprehensive product description
- References to harmonized standards or other technical specifications employed
- Identification of the signatory
This document is, where applicable, accompanied by the certificate issued by the engaged notified body.
The Technical Filing
In addition to the declaration, conformity assessment procedures ordinarily necessitate the compilation of a technical file by the manufacturer. The aim of this document is to substantiate the product’s compliance. It should encompass administrative details concerning the company and assorted documents facilitating verification of the product’s alignment with technical regulations (e.g., test reports, product and process descriptions, blueprints, etc.).
This file is not obligated to accompany the product and need not be proactively presented. Only market surveillance authorities possess the prerogative to access it.
Consequences of CE Marking
Any product subject to a directive mandating the CE marking cannot be introduced to the market sans this emblem.
Once endowed with the CE marking, such a product enjoys unrestricted movement within the European market.
National product safety surveillance authorities (customs officials or DGCCRF) may demand the production of the declaration of conformity and the technical dossier to substantiate the legitimacy of the CE marking.