Declaration of Conformity: Everything You Need to Know to Ensure Safe and Compliant Products with CE Marking

CE Mark

The Declaration of Conformity is a mandatory document for all products subject to CE marking, and it must be issued by the manufacturer. This document officially declares that the product meets all European Union legal requirements, and the manufacturer assumes responsibility for its compliance and safety.

Products covered by the CE marking must bear the CE symbol, indicating that the product complies with European legislation and can be freely marketed within the European Economic Area (EEA).

Which title is correct: EU Declaration of Conformity or CE Declaration of Conformity?

This is one of the most frequently asked questions by manufacturers. Both terms are correct, with the appropriate terminology depending on the applicable legislation for the specific product type.

• CE Declaration of Conformity: Used in accordance with Directives, such as Directive 2009/48/EC on the safety of toys (Article 15).

• EU Declaration of Conformity: Applied when the product is regulated by a European Regulation, such as Regulation (EU) 2017/745 on medical devices (Article 19).

Key Points About the Declaration of Conformity

Para garantir a conformidade legal dos seus produtos, é essencial conhecer os To ensure the legal compliance of your products, it is essential to understand the following aspects:

• Mandatory for all products subject to CE marking;

• Must be issued before the product is placed on the market;

• Demonstrates that the product meets the essential health, safety, and environmental requirements of the EU;

• Must accompany the product or be easily accessible to consumers and authorities (e.g., on the packaging, website, etc.);

• Reflects the manufacturer’s responsibility for the product’s compliance;

• Must contain mandatory information as defined by the applicable legislation and be kept up to date;

• Must be translated into the official language(s) of the EU Member State(s) where the product is made available.

What Are the Mandatory Elements in a Declaration of Conformity?

The content of the Declaration of Conformity may vary depending on the applicable Directive or Regulation, but there are key elements that must always be included:

• Manufacturer identification: full name, address, and, if applicable, EU registration number;

• Authorised representative identification (if applicable): full details of the appointed entity within the European Union;

• Clear product identification: type, model, serial number, or other unique identifier;

• References to applicable Directives, Regulations, or Harmonised Standards with which the product complies;

• Explicit declaration of conformity with the relevant requirements;

• Additional information: such as test results, conformity assessments, or certificates issued by third parties (if available);

• Date of issue and signature of the manufacturer's legal representative.

  
  

These elements are crucial to ensure traceability, transparency, and legal accountability in the process of placing products on the market.

EU Declaration of Conformity

Need Support with CE Marking for Your Products?

Cinterqual is a specialist in regulatory compliance processes and can act as your Authorised Representative in the European Union. We provide technical and documentation support throughout all stages of the CE Marking process, ensuring your products are fully prepared for the European market in full compliance with applicable legislation.

👉 Contact us today to learn how we can support your CE Marking project!