CE marking
The CE marking is governed by European Union (EU) legislation and regulations. It indicates that a product complies with essential health and safety requirements set out in relevant EU directives. Here’s a breakdown of the key aspects:
EU Directives: The CE marking process begins with identifying the applicable EU directives for your product. These directives outline the essential requirements that products must meet to be legally placed on the market within the European Economic Area (EEA).
Conformity Assessment: Once the directives applicable to your product are identified, you need to ensure conformity through a conformity assessment procedure. The specific procedure varies depending on the type of product and the applicable directive. It may involve self-certification by the manufacturer or assessment by a notified body (a third-party organization designated by an EU member state).
Technical Documentation: Manufacturers must compile technical documentation demonstrating how the product meets the essential requirements of the relevant directives. This documentation should be kept on file and made available to authorities upon request.
CE Marking: Once the product has undergone the necessary conformity assessment and meets all applicable requirements, the manufacturer affixes the CE marking to the product. The CE marking should be affixed visibly, legibly, and indelibly to the product or its packaging.
Declaration of Conformity: Along with affixing the CE marking, the manufacturer must issue a Declaration of Conformity (DoC). This document declares that the product complies with all relevant EU directives and standards. The DoC should also include information such as the manufacturer’s details, product identification, and conformity assessment procedures followed.
Obligations of Economic Operators: Besides manufacturers, other economic operators such as importers and distributors also have obligations under the CE marking regulations. Importers must ensure that products they place on the market comply with CE marking requirements, while distributors must verify that products bear the CE marking and are accompanied by the required documentation.
Relevant references and standards include:
EU Directives: These vary depending on the product type. Common directives include the Machinery Directive (2006/42/EC), the Low Voltage Directive (2014/35/EU), and the Medical Devices Directive (93/42/EEC).
EN Standards: Harmonized European standards provide technical specifications for demonstrating compliance with EU directives. These standards are voluntary but provide a presumption of conformity with the essential requirements of the directives when followed.
Notified Bodies: These are organizations designated by EU member states to perform conformity assessment tasks for certain product categories. They assess whether products meet the relevant requirements of the directives and issue certificates of conformity where applicable.
It’s crucial for manufacturers to thoroughly understand the requirements of the specific directives applicable to their products and ensure compliance throughout the design, production, and distribution processes. Failure to comply with CE marking requirements can result in products being removed from the market and legal consequences for the manufacturer.
