Since its adoption in 1985, CE marking has been a mainstay of European trade and commerce. For manufacturers, applying a CE mark has a number of 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 and technical requirements can be a daunting task. Our experts help you understand and apply the directives that pertain to your product, and successfully complete the certification process.
Given the extensive reach of CE marking, it isn’t surprising that most products require compliance to at least one of more than 25 major directives that govern product certification. From toys and textiles to electronics and power tools, almost all products that consumers interact with on a daily basis require a CE mark to be sold in the EU. Despite the ubiquity of this legislation, however, many companies struggle with understanding what, exactly, CE marking is.
Frequently Asked Questions (FAQs)
What is CE Marking? What are CE Marking directives? What are technical files and Declarations of Conformity (DoC)? How do I complete CE Marking?
What is CE Marking?
CE marking is a mandatory conformity label that allows for the free movement of goods across the European Union. Because this legislation supersedes the laws of individual countries, products that carry a CE mark are authorized for sale in all EU Member States without additional technical or regulatory requirements.
What are CE Marking Directives?
The CE marking process is driven by the use of directives. 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 of the art to change regularly without the legal text of the directive needing to be updated.
Determining which directive(s) applies to your product can be a challenge, considering that most directives are written in a legal form rather than for laypersons and is often buried in the directive itself. An important 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, labelling or instructions.
Given the complex task of identification of the directive and harmonized standards, coupled with interpretation of the wording, Element offers guidance through its Early Stage Qualification (ESQ®) team.
What is a Notified Body?
A Notified Body (NB) is an organization that has been approved by the EU Commission to provide type-examination to manufacturers seeking a CE mark. Working with a Notified Body can greatly mitigate the risks of choosing the wrong directive, critical defect or safety failure, or being found non-compliant in the administrative requirements of CE marking.
For directives that are particularly safety-critical, review by a Notified Body is a mandatory step in declaring compliance. In these cases, we can provide the necessary testing to prove product safety and fitness, and assist in creating technical files. Element is a Notified Body for a number of CE marking directives, including The Radio Equipment Directive, Machinery Directive, EMC Directive, and Explosive Atmosphere (ATEX) Directive.
Please contact us for a full list of Notified Body services.
What are Technical Files and Declarations of Conformity (DoC)?
In order to CE mark your product, you will need to compile a list of documentation proving that it meets certain criteria for performance, safety, and functionality. Known as a technical file, this should include design drawings, diagrams, technical rationales, test reports, instructions for use, supporting documents from a Notified Body (if required), and any other evidence that proves the product complies with the directive.
Once this is compiled, a Declaration of Conformity (DoC) needs to be completed for the product being marked. During this step, you will collate the information in your technical file and any other pertinent product information, and will sign a Declaration of Conformity, declaring that the product meets all the requirements of the applicable CE Marking directives. This is a legally binding document that unequivocally states that your product is safe for use, and meets all of the required directives and harmonized standards, where applicable.
Once this is completed, you are ready for the last step in the process – CE marking certification.
How Do I Complete CE Marking?
On the whole, CE marking is a self-declaration process, meaning that you will apply the mark to your product and declare compliance without any additional input from a regulatory agency (for some products, the Notified Body will need to issue a Type Examination certificate confirming that they have assessed the technical file(s) against the directive. Once the mark is affixed, your product can be sold anywhere in the EU and European Economic Area (EEA) without needing additional certification from individual Member States.
Any product can be audited at any time by a European Market Surveillance authority, so it’s important to keep the technical file for your product in its entirety, and to perform regular testing of your products to confirm ongoing compliance to the technical requirements. CE marking requires that every product sold conforms to its requirements, so batch testing and ongoing quality assurance are necessary for maintaining compliance.
CE marking can be a difficult and confusing process to complete. Element is here to support your journey to certification through every step, from design guidance and testing to compiling and storing technical files and completing routine maintenance testing. In addition to our testing services, our team of Early Stage Qualification (ESQ®) experts provide input on compliance strategies and test plans, and can help with global approvals when you’re ready to take your product to other markets around the world. No matter where you are in the CE marking process, we can help make your project a success.
For more information about CE marking and how to certify your products, or to request a quote, contact an expert today.
The CE Marking Process
For most products, CE marking follows an 8-step process to certification.
Although it may seem like a complicated process, CE marking follows 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 includes:
- 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)
- CE Marking 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 deliver best practice guidance with flexible standard and bespoke packages to meet your business and staff needs.
Testing and Notified Body Services for CE Marking
Our seasoned engineers will perform your product testing to the required standards, and deliver comprehensive reporting to support your technical documentation. We are a leading provider of testing on electrical and mechanical devices including:
- EMC testing
- Radio testing
- Explosive Atmospheres (ATEX) testing
- Low voltage device testing
- Product safety testing
- Medical device testing
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:
Should you want to export your products outside the European Union, our Certification and Global Approvals teams can assist in providing the testing and documentation needed to gain access to 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.
List of CE Marking Member States
CE marking allows you access to the EU Member States, as well as countries in the European Economic Area (EEA).
CE marking allows you to freely trade your products in the following countries:
- Czech Republic
- United Kingdom
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Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.
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