Transitional period and CE marking obligations
The transitional period is the phase in which a European Directive is being implemented, but compliance is not yet mandatory. During this time, CE marking is optional, allowing products to temporarily comply with the national standards of each Member State. However, once the transitional period ends and the Directive enters into force, CE marking becomes a legal requirement . All products covered by the Directive must bear the CE marking to be marketed in the European Union, ensuring uniform conformity across the European market.
The CE Marking gives you
Free movement of goods Access to new markets Consumer confidence
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Responsibilities of economic operators for CE Marking . Manufacturer, importer, authorized representative and distributor must ensure compliance with the conformity requirements that affect their products.
Manufacturer's Responsibilities for CE Marking
Manufacturer is primarily responsible for ensuring that its product complies with the essential requirements of the applicable Directives, and must take the following steps to comply with CE marking:
- Ensure product compliance with the essential safety, health and environmental protection requirements specified in the applicable Directives.
- Sign the "EC" Declaration of Conformity, which certifies that the product complies with EU standards.
- Prepare and maintain technical documentation or technical file necessary to verify compliance.
- Affix the "CE" marking on the product, ensuring that it is visible and meets requirements.
Role of the legal representative or agent
If the manufacturer is not established in the European Union, they can appoint a legal representative or agent within the EU. This is optional, except in cases of mandatory certification, where it becomes essential for imported products. The legal representative assumes certain administrative responsibilities, such as:
- Maintenance of technical documentation for compliance checks.
- Submission of the application for EC type-examination, when required.
- Signature of the "EC" Declaration of Conformity on behalf of the manufacturer, if so provided by the Directive.
Obligations of the distributor or importer in the absence of a manufacturer or representative
When neither the manufacturer nor its representative is established in the European Union, the person placing the product on the Community market (importer or distributor) assumes the same responsibilities as the manufacturer or its representative. In this case, they must:
- Ensure that the product meets the essential requirements of the applicable Directives.
- Provide relevant documentation, including the declaration of conformity and the technical file, for control purposes.
Considerations for EU manufacturers
A manufacturer established within the European Union cannot delegate its compliance and safety responsibilities to other actors, such as resellers or wholesalers. This ensures that products manufactured within the EU maintain quality and safety standards, benefiting both consumers and the EU market as a whole.