Manufacturers preparing industrial equipment for a new market often encounter two concepts that can sound similar: CE marking and third-party certification. Both can be associated with product compliance, but they do not represent the same process or serve the same purpose.
For manufacturers placing machinery, control panels, and other electrical equipment on the European market, understanding this distinction is especially important. The applicable conformity route affects who is responsible for demonstrating compliance, what documentation is required, and whether an independent certification organization needs to become involved.
What You Can Expect To learn In the Video and Blog
- What CE marking represents
- The manufacturer's responsibilities in the CE marking process
- How harmonized standards support conformity
- How third-party certification differs from CE marking
- When independent testing or certification may become necessary
- Why market-specific requirements should be identified early
What Is CE Marking?
CE marking indicates that a product has been assessed for conformity with the applicable European requirements.
For manufacturers, this is more than simply placing the CE symbol on a product. The manufacturer is responsible for determining which European directives apply, evaluating the product against the relevant requirements, completing the necessary conformity assessment, preparing supporting technical documentation, and issuing an EU Declaration of Conformity.
The manufacturer then affixes the CE marking as a declaration that the product complies with the applicable requirements.
For industrial and machine control panels, multiple directives may apply to the same product. When this occurs, the applicable requirements of each relevant directive must be addressed.
The Role of Harmonized Standards
European directives establish essential requirements, but they do not necessarily provide detailed engineering instructions for meeting them.
Harmonized standards help bridge that gap.
These standards provide manufacturers with detailed technical guidance that can be used when designing and evaluating equipment. When an applicable harmonized standard is properly followed, it can provide a presumption of conformity with the essential requirements addressed by that standard.
For industrial machinery and control panels, examples can include standards such as:
- IEC/EN 60204-1 for the electrical equipment of machines
- IEC/EN 61439-1 for low-voltage switchgear and controlgear assemblies
- IEC/EN 61439-2 for power switchgear and controlgear assemblies
- ISO/EN ISO 12100 for machinery risk assessment and risk reduction
Choosing the appropriate standards depends on the equipment, its intended use, and the directives that apply.
Does CE Marking Require Third-Party Certification?
Not necessarily.
One of the most important distinctions between CE marking and third-party certification is that independent certification is not automatically required for CE marking.
Within the European Economic Area, manufacturers are responsible for ensuring that their products meet the applicable safety objectives. They certify conformity with applicable directives through CE marking and an EU Declaration of Conformity. Acceptance testing by an independent certification institute is not mandatory within the EEA.
This means CE marking should not automatically be interpreted as evidence that an independent laboratory or certification organization has tested or approved the product.
Instead, CE marking represents the manufacturer’s declaration that the applicable conformity requirements have been satisfied.
What Is Third-Party Certification?
Third-party certification introduces an independent organization into the conformity process.
Certification organizations and testing laboratories may evaluate equipment against applicable technical requirements. Depending on the market and product, this process can include product testing, documentation review, manufacturing audits, or other conformity assessment activities.
The key distinction is who is performing or validating the conformity assessment.
With CE marking, responsibility generally rests with the manufacturer under the applicable conformity procedure. With third-party certification, an independent organization becomes involved in evaluating or certifying conformity.
Third-party involvement may also be useful in cases where manufacturers need additional evidence that applicable requirements have been met. For example, when a manufacturer chooses not to rely on harmonized standards to demonstrate conformity, additional risk analysis and evidence may be required, and third-party services may be appropriate in some circumstances.
CE Marking Is About European Market Access
Another important distinction is that conformity requirements depend heavily on the market where equipment will be placed.
CE marking is associated with European product requirements and allows compliant products covered by the applicable legislation to circulate within the relevant European market framework. By applying the CE marking, the manufacturer declares that the product has been assessed for conformity with the applicable requirements.
Other markets can operate differently.
Outside the European Economic Area, manufacturers may encounter separate test marks, administrative marks, certification schemes, or national requirements. Some markets may require product-specific testing or manufacturing audits before covered products can be imported or sold.
As a result, a product designed for international distribution may need more than one compliance strategy. CE marking for Europe does not automatically establish compliance with the requirements of every other market.
Certification Requirements Depend on the Product and Destination
There is no universal certification route that applies to every industrial product worldwide.
Requirements can vary based on:
- The country or economic region
- The type of equipment
- The product’s intended application
- The applicable directives, regulations, and standards
- Whether a particular certification or conformity mark is mandatory
Even individual components and completed control panels can be treated differently. A component may require a particular mark while the completed assembly may be subject to a different conformity process. Therefore, market-access requirements should be evaluated on a product-by-product and destination-by-destination basis.
This is why it’s advised that manufacturers determine their target markets early in the product development process. Waiting until equipment is ready to ship can reveal compliance requirements that require additional documentation, testing, evaluation, or even design changes.
CE Marking and Third-Party Certification Are Not Interchangeable
Although both relate to conformity, the terms should not be used interchangeably.
CE marking is a manufacturer’s declaration that a product meets the applicable requirements of relevant European legislation. It involves determining applicable directives and standards, assessing conformity, developing technical documentation, issuing the required declaration, and applying the CE mark.
Third-party certification involves an independent certification organization or testing body evaluating a product against specified requirements. Whether that involvement is mandatory depends on the product, conformity procedure, and destination market.
Understanding that distinction can prevent manufacturers from either pursuing unnecessary certification or assuming that CE marking alone satisfies requirements in markets where additional approvals are required.
How HTDS Can Help
Determining the correct compliance path requires more than identifying a standard or adding a certification mark at the end of product development.
High Tech Design Safety helps manufacturers evaluate their equipment, identify applicable standards and requirements, review designs and documentation, address nonconformities, and work toward the appropriate conformity or certification path for the intended market.
For manufacturers pursuing CE marking, HTDS can help identify applicable requirements and support the technical evaluation and documentation process. When independent certification is required, HTDS can help manufacturers prepare their equipment and documentation for the certification process.
Addressing these requirements early can reduce uncertainty and help prevent avoidable compliance issues later in the project.
Summary
Key Takeaways
- CE marking and third-party certification are different conformity approaches.
- CE marking demonstrates the manufacturer’s declaration of conformity with applicable European requirements.
- Applicable harmonized standards can provide a presumption of conformity with requirements they address.
- Independent certification is not automatically required for products placed on the EEA market.
- Third-party testing or certification may still be appropriate or required depending on the product, conformity procedure, and destination.
- Requirements outside Europe can include separate certification, testing, auditing, and product-marking systems.
- Manufacturers should identify applicable requirements based on both the product and its intended market.
- Addressing compliance during product development can make the path to market significantly more manageable.
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What should you check out next? Understanding Harmonized Standards for CE Compliance, A Guide to CE Marking for Industrial Machinery, How To Approach Product Compliance If Your Equipment Is Already Designed
