The CE Marking process can often be misunderstood. Whether you are new to CE Marking, run a business and need to learn more about it, or simply wish to refresh your knowledge, this guide explains the conformity process in easy-to-understand steps.
What Does ‘CE’ Mean?
CE stands for ‘Conformité Européene,’ which translates to ‘European Conformity.’ Although often referred to as a ‘CE Mark,’ the correct term is ‘CE Marking,’ used in various product directives.
What Does CE Marking Mean?
A CE mark on a product signifies its compliance with relevant EU health, safety, and environmental protection legislation. For UK manufacturers and exporters, CE Markings are essential for ensuring free movement of their products within the European Free Trade Association (EFTA) and the European Union (EU) single market, earning it the nickname ‘a passport for products.’
What Types of Products Need CE Marking?
Determining if a product requires CE Marking can be complex, depending on the target markets and whether they are within the EEA or EFTA. Here are some product categories covered by at least one CE marking directive:
- Active implantable medical devices
- In vitro diagnostic medical devices
- Cableways
- Construction products
- Electrical equipment
- Electronic equipment
- Equipment and protective systems used in explosive atmospheres
- Explosives for civil use
- Gas appliances
- Lifts
- Machinery
- Measuring Equipment
- Medical devices
- New hot water boilers
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio and Telecommunications terminal equipment
- Recreational craft
- Simple pressure vessels
- Toys
Products that do not require CE Marking include chemicals, cosmetics, foodstuffs, and pharmaceuticals.
The CE Marking Process Explained
The CE marking process can be overwhelming for manufacturers without prior experience. Here is a brief overview of the main steps involved:
- Identifying the Applicable Directive(s)
- Determine the Relevant Standards
- Notified Body Assessment (if applicable)
- Testing of Product (external or internal)
- Compile Technical Documentation
- Create a Declaration of Conformity for the Product
- Labelling and Marking the Product
Step 1 – Identifying the Applicable Directive(s)
First, determine whether the product requires CE Marking and the relevant directives and regulations. EU directives outline the essential requirements a product must meet to enter the EU single market. Most non-food products fall under at least one directive, but compliance with multiple directives may be necessary for CE Marking approval.
Step 2 – Determine the Relevant Standards
Manufacturers must identify applicable standards specifying the vital requirements and technical specifications for product safety. Harmonized standards within each directive cover the essential requirements, ensuring compliance with corresponding directives when met.
Step 3 – Notified Body Assessment (if applicable)
Certain products require third-party assessment by an EU-accredited Notified Body to evaluate compliance. A Notified Body conducts conformity-related tasks such as test reports, inspections, and reviews of technical files. Consulting with a CE Marking expert early can simplify and expedite this process.
Step 4 – Testing of Product (external or internal)
Compliance testing, either internally or externally, verifies that the product meets EU directive requirements. For products not requiring a Notified Body, this step can sometimes be performed in-house, involving risk analysis and management.
Step 5 – Compile Technical Documentation
Compile all relevant information and results from the testing process into technical documentation, or a ‘technical file,’ demonstrating that the product meets safety requirements. This documentation typically includes:
- A general product description.
- Design information such as drawings, circuit diagrams, and component lists.
- Detailed descriptions of the design, installation, and user manual.
- A list of standards used for compliance verification.
- Additional documents like calculations, simulations, and test reports.
- A copy of the EU Declaration of Conformity.
Manufacturers must store the technical file for a specified period, usually around 10 years, and provide it to national market authorities if required.
Step 6 – Create a Declaration of Conformity for the Product
After compiling technical documents and ensuring compliance with EU requirements, complete the Declaration of Conformity. This legal document, signed by the company CEO or product owner, states that the product meets all relevant safety requirements.
Step 7 – Labelling and Marking the Product
Finally, affix the CE mark to the product’s surface or packaging. Along with the Declaration of Conformity, this mark indicates that the product complies with CE marking legislation.
CE Marking Consultancy Services
For further questions about CE Marking, please contact us. Our team of knowledgeable, highly experienced consultants can provide guidance and assistance to simplify the CE marking process, ensuring a smoother path to approval.