Element’s experts assist manufacturers of consumer products in ensuring they are compliant with CE mark testing requirements for goods to be sold within the European Union.
CE marking is a mandatory European conformity label that allows for the free movement of goods. Because this legislation supersedes individual countries' laws, products that carry a CE mark are authorized for sale in all EU Member States without additional technical or regulatory requirements.
For manufacturers, applying a CE mark has many advantages, including unrestricted trade within the European Union, enhanced product safety, and reduced environmental impact. However, navigating the complex web of risk analysis, harmonized standards, technical and legal requirements can be daunting.
Our experts help you understand and apply the directives that pertain to your product and complete the certification process. From toys and textiles to electronics and power tools, Element have the expertise and knowledge to ensure you get your products to market quickly, safely and efficiently.
What are the CE mark testing requirements?
The use of directives drives the CE mark testing requirements. A directive is a piece of legislation that is drafted and approved by the European Commission and must be integrated into the legal systems of each Member State. Used to provide minimum requirements for a particular category of products, most directives are intentionally vague about specific requirements for testing and compliance and focus on 'essential requirements'. The subordinate harmonized standards contain the technical details that a product must comply with, thus allowing the state to change regularly without the directive's legal text needing to be updated.
Determining which directive(s) applies to your product can be challenging, considering that most directives are written in a legal form rather than for laypersons and is often buried in the directive itself. An essential step in compliance with a directive is performing a risk assessment. This is the process where a manufacturer identifies all the hazards covered by the directive and then mitigates these hazards through a test assessment (typically using a harmonized standard(s)) or through a modification to the design, labeling, or instructions.
CE marking must be placed on the product within the EEA or Turkey.
The CE marking process
For most products, CE marking follows an 9-step process to certification.
Although it may seem like a complicated process, CE marking requirements follow a relatively simple set of steps. Our experts can assist in every stage of this journey, from determining the appropriate requirements to maintenance testing.
The CE marking process is as follows:
- Determining the requirements
- Identifying the appropriate standard (includes involving a Notified Body as needed and creating a test plan)
- Performing the testing / applying the standards
- Compiling technical information (includes completing a Notified Body review if needed and issuing a Statement of Opinion (SoO) if required)
- Generating a Declaration of Conformity (DoC)
- Affix the CE Marking on products / equipment
- Placing equipment on the market (putting the product into service)
- Maintaining compliance through regular testing and auditing
If you require guidance on the CE Marking process and how it applies to you and your products, Element’s CE Marking Training courses are delivered by seasoned subject experts. They can address your questions and provide best practice guidance with flexible standard and bespoke packages to meet your business and staff needs.
The Element advantage
Our engineers will perform your product testing to the required standards and deliver comprehensive reporting to support your technical documentation. Element is the leading provider of testing on electrical and mechanical devices.
We can also provide the necessary third-party environmental testing to support your risk assessment and identification of hazards. You can combine your testing into a single test program to save time and money.
We provide Notified Body services to the following CE Marking Directives:
- The Radio Equipment Directive
- EMC Directive
- ATEX Directive Explosive Atmosphere
- Low Voltage Directive
- Medical Device Directive
Should you want to export your products outside the European Union, our Certification and Global Approvals teams can provide the testing and documentation needed to access worldwide markets. With experience helping clients become certified for export to North America, Asia, South Africa, and beyond, we leverage our global platform to give your products and your business international reach.
To request a CE marking quote, or if you have any questions about CE mark testing requirements, contact us, and one of our experts will contact you shortly.
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