Compliance professional preparing a product Declaration of Conformity

Product Conformity Declaration

Choosing the right CE marking conformity assessment pathway is a critical step toward successful product certification and global market access in Europe. While both self-certification and third-party certification are recognized under EU legislation, the appropriate approach depends on the product category, its intended use, and the applicable directives or regulations. For higher-risk products—including medical, industrial, and wireless devices—working with a Notified Body and an ISO/IEC 17025 accredited testing laboratory provides greater confidence that all regulatory requirements have been met. Combining expert guidance with comprehensive EMC testing services, RF testing, EMC compliance testing, and well-prepared technical documentation helps streamline the CE marking process, reduce compliance risks, and accelerate access to European and global markets.

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Declaration of Conformity

For CE marking, manufacturers can follow one of two conformity assessment pathways depending on the product and the applicable EU legislation: self-certification or third-party certification. Many low-risk products can be self-certified, allowing manufacturers to demonstrate compliance by preparing the required technical documentation, performing the necessary evaluations—including EMC testing, RF testing, and applicable safety assessments—and issuing an EU Declaration of Conformity. Higher-risk products, however, require assessment by an independent Notified Body, which reviews the product, technical documentation, and conformity assessment process before it can be legally placed on the European market. Although self-certification can reduce both cost and time to market, it also places full responsibility for regulatory compliance on the manufacturer.

Professionals reviewing an EU Declaration of Conformity

What Is a Declaration of Conformity?

A DoC is an official statement by the manufacturer or authorized representative declaring that the product complies with the essential requirements of the regulations that apply to it.
For example, in Europe this includes directives such as:

  • EMC Directive 2014/30/EU
  • Radio Equipment Directive (RED) 2014/53/EU
  • Low Voltage Directive (LVD) 2014/35/EU
  • RoHS Directive 2011/65/EU

The DoC must reference the harmonized standards used to demonstrate conformity, such as CISPR, IEC/EN 61000-x series, ETSI radio standards, and other applicable frameworks.

Engineer reviewing product documentation for a Declaration of Conformity

How Stancer Testing-Lab Supports Your DoC

The EU Declaration of Conformity (DoC) is a mandatory legal document for most products bearing the CE mark. It serves as the manufacturer’s formal declaration that the product complies with all applicable European directives and regulations, including requirements related to safety, electromagnetic compatibility, and environmental protection. A complete DoC should identify the applicable legislation, include the manufacturer’s or importer’s name and contact information, and be signed by an authorized representative who accepts legal responsibility for the product’s compliance. When third-party conformity assessment is required, the Declaration should also reference the involved Notified Body and the relevant conformity assessment procedures. Supported by comprehensive EMC testing, RF testing, and a well-prepared technical file, an accurate Declaration of Conformity is essential for obtaining CE marking, demonstrating regulatory compliance, and ensuring successful access to the European market.

As an ISO/IEC 17025–accredited EMC/RF testing laboratory, Stancer Testing-Lab provides the accredited evidence required
to support a compliant DoC. We assist by:

  1. 1. We determine which EMC, RF, and wireless standards apply based on your product type, operating frequencies, and target markets.
  2. 2. All tests are executed in our accredited facilities, ensuring that the results meet the requirements of EU, UK, North American, and global regulatory bodies.
  3. 3. We generate complete, traceable test reports and support files that form the backbone of the technical documentation required under EU law.
  4. 4. We help structure the document correctly, ensuring that it includes all required elements such as:
  • Applicable directives
  • Standards used
  • Regulatory contact details
  • Product identification
  • Reference to certified testing

This ensures your DoC is acceptable to market surveillance authorities, customs, and certification bodies.

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