Duration of Production and Documentation Requirements for DoC Under CE Marking
Duration of Production and Documentation Requirements for DoC Under CE Marking
The Declaration of Conformity (DoC) is a critical document for manufacturers producing goods that need to bear the CE marking. Both the production and documentation requirements for the DoC under CE marking are crucial to ensure compliance with relevant European Union legislation. This article aims to clarify the legal obligations for manufacturers regarding the production and documentation of DoCs for CE marking.
Production Obligations for DoC
The main principle of the Declaration of Conformity is that a manufacturer shall produce it as long as the product remains on the market. This is a foundational requirement that ensures consumers and authorities can verify the product's compliance with CE marking regulations throughout its lifecycle.
manhfacturer Obligations When a Product Ceases Production or Sale
Once a product is no longer in production or on the market, the manufacturer's obligations for producing DoCs may differ. The following sections explore the specific requirements under different regulations and scenarios.
Duration of Production of DoC After Product Ceases Production or Sale
When a product is no longer produced or sold, a manufacturer is still required to produce and maintain the Declaration of Conformity (DoC), but the duration of its production can vary depending on the specific regulations and directive applicable to the product.
For example, the Low Voltage Directive (LVD) requires a product to be compliant for a minimum of five years from the date of manufacture. Similarly, the Electromagnetic Compatibility Directive (EMC) mandates a similar period, ensuring that any DoC issued remains valid for a minimum of 10 years from the date of issuance.
Documentation Requirements and Retention Periods
Documentation is a critical component of the CE marking process. It includes various records necessary to verify that the product meets the essential requirements of the applicable harmonized standards and regulations. The retention periods for these documents are outlined in the relevant directives and harmonized standards.
Documentation Requirements
The documentation requirements for the Declaration of Conformity often include:
Technical documentation Process plans and instructions related to the technical file Records of design and manufacturing processes Validation records Records of maintenance and staff competency Records of raw material supplier validationRetaining Documentation for CE Marking
As mentioned earlier, the retention period for documentation is often longer than the production period. If the regulations or standards specify a period, that period must be adhered to. For instance, under the Pressure Equipment Directive (PED), the documentation must be retained for a period of 10 years from the date of the last production or installation of the equipment.
In cases where the directive or harmonized standard does not specify a retention period, the documentation shall be retained for as long as the product is in use, plus a legal protection period after the product is no longer in use. For example, under the Machinery Directive and the Restriction of Hazardous Substances Directive (RoHS), the documentation must be retained for 10 years after the last product was placed on the market.
Conclusion
In conclusion, the production and retention of documentation for the Declaration of Conformity under CE marking are critical responsibilities for manufacturers. The duration of these obligations can vary depending on the specific regulations and directives applicable to the product. It is essential for manufacturers to stay informed about the latest requirements and to maintain thorough documentation to ensure compliance with the CE marking process.