Introduction

The EC Declaration of Conformity is a critical document that certifies a product's compliance with the relevant European Union (EU) directives and regulations. It is a legal requirement for most products sold within the European Economic Area (EEA) that fall under the scope of CE marking. This document ensures the product meets essential health, safety, and environmental protection standards and is authorized for free movement within the EEA.

What is the EC Declaration of Conformity?

The EC Declaration of Conformity (DoC) is a formal, self-issued statement by a manufacturer (or their authorized representative) affirming that a product complies with all applicable EU legislation. The declaration is a vital part of the CE marking process, serving as documented proof that the necessary conformity assessment procedures have been carried out.

Once completed, the declaration allows the manufacturer to affix the CE mark to the product, enabling it to be marketed across the EU and EEA without restrictions.

When is it required?

A product requires an EC Declaration of Conformity if:

  • It is covered by one or more EU CE marking directives or regulations.
  • It is placed on the EU or EEA market.
  • It is mass-produced or individually manufactured for specific use (e.g., in machinery or medical devices).

Typical product categories requiring an EC DoC include:

  • Machinery
  • Electrical and electronic equipment
  • Construction products
  • Toys
  • Personal protective equipment
  • Medical devices
  • Pressure equipment
  • Measuring instruments

Applicable Legal Directives and Regulations

Some of the most commonly applicable EU legislation requiring a Declaration of Conformity includes:

  • Machinery Directive (2006/42/EC)
  • Low Voltage Directive (2014/35/EU)
  • EMC Directive (2014/30/EU)
  • Radio Equipment Directive (2014/53/EU)
  • Toy Safety Directive (2009/48/EC)
  • Personal Protective Equipment Regulation (EU) 2016/425
  • Medical Device Regulation (EU) 2017/745

Each piece of legislation may specify particular safety and performance standards and conformity assessment procedures that must be followed.

Who is Responsible for the Declaration?

The responsibility for drafting and signing the EC Declaration of Conformity lies with:

  • The manufacturer is based in the EU.
  • The authorized representative, if the manufacturer is based outside the EU and has appointed a representative within the Union.

Importers and distributors are also legally required to ensure that a Declaration of Conformity exists and that the product complies with relevant legislation before placing it on the market.

Required Content of the EC Declaration of Conformity

While formatting can vary depending on the legislation, the following information is typically required:

  1. Product identification (e.g., model, type, batch, or serial number)
  2. Manufacturer’s name and address
  3. Authorized representative’s name and address (if applicable)
  4. A statement of responsibility
  5. Reference to relevant EU directives or regulations
  6. List of harmonized standards or normative documents used
  7. Identification of the notified body (if involved in the conformity assessment)
  8. Place and date of issue
  9. Name and function of the person signing
  10. Signature

Example of an EC Declaration of Conformity

EC Declaration of Conformity-Shenzhen Shengye Technology Co.,Ltd

Storage and Availability

Manufacturers must:

  • Retain the EC Declaration of Conformity for at least 10 years after the product has been placed on the market.
  • Provide the document to market surveillance authorities upon request.
  • Ensure it is translated into the official language(s) of the country where the product is sold if necessary.

Consequences of Non-Compliance

Failure to issue or maintain a proper EC Declaration of Conformity can result in:

  • Fines and penalties
  • Product recall or market withdrawal
  • Liability claims
  • Damaged reputation

EU market surveillance authorities have the power to inspect and enforce compliance, and businesses that fail to meet requirements may lose access to the EEA market.

Conclusion

The EC Declaration of Conformity is much more than a bureaucratic requirement—it is a binding legal statement ensuring product compliance with EU regulations. It reflects a commitment to consumer safety, product reliability, and regulatory transparency. Any manufacturer looking to access the European market must understand its importance and ensure that it is properly prepared, maintained, and accessible when needed.

By adhering to these requirements, manufacturers not only avoid legal pitfalls but also reinforce customer trust in their product’s safety and quality.