CE Marking

CE Certification | CE Marking: Introduction

Many products need CE Certification or CE Marking before entering the European Union (EU) market. To begin with, Conformité Européenne (CE) Marking shows that the manufacturer has assessed the product and confirmed it meets essential EU requirements for safety, health, and environmental protection. Additionally, this certification applies to products manufactured both within and outside the EU. By securing CE Certification, businesses demonstrate compliance with European standards and gain legal access to the European Union (EU) market. Moreover, CE Marking builds customer trust, enhances product credibility, and supports smoother cross-border trade. Therefore, companies aiming for EU expansion must prioritize CE compliance from the start.

What is CE Certification / CE Marking?

CE Certification or CE Marking is a mandatory conformity mark for products sold within the European Economic Area (EEA). To begin with, “CE” stands for Conformité Européenne, meaning European Conformity. CE Marking indicates that a product meets the essential requirements of EU directives related to safety, health, and environmental protection. Through the CE Certification process, manufacturers evaluate their products, conduct necessary testing, prepare technical documentation, and issue a Declaration of Conformity. Once complete, they affix the CE Marking to the product. This mark allows legal market entry, supports free movement within EU countries, and enhances consumer trust.

Why CE Certification / CE Marking:

CE Certification or CE Marking plays a vital role in gaining access to the European market. To start with, it confirms that your product complies with essential EU safety, health, and environmental standards. Next, it allows free movement of goods within the European Economic Area without additional restrictions. By obtaining CE Certification, you show customers and regulators that your product meets high-quality standards. Moreover, CE Marking reduces legal risks and increases credibility with distributors and end-users. In the end, when you follow the CE Certification process, you create new business opportunities and strengthen your product’s market acceptance across Europe.

Benefits of CE Marking to business?

1. Access to the EU Market: CE Marking allows you to sell your products freely within the European Economic Area (EEA), expanding your market reach.

2. Legal Compliance: By completing CE Certification, you ensure your product meets EU regulations, avoiding fines and market bans.

3. Increased Customer Trust: CE Marking builds consumer confidence by showing that your product meets strict safety, health, and environmental standards.

4. Competitive Advantage: CE Certified products stand out in global markets, giving your business a reputation for quality and compliance.

5. Reduced Liability Risks: Proper CE Certification helps reduce the risk of product recalls, legal claims, and reputational damage.

6. Simplified Trade: With CE Marking, you eliminate technical barriers, making it easier to trade across EU member states without additional testing.

CE Marking applies to the following products

1. Electrical and Electronic Equipment
(e.g., home appliances, IT equipment, audio/video devices)

2. Medical Devices
(e.g., surgical instruments, diagnostic equipment, implants)

3. Machinery
(e.g., industrial machines, power tools, construction equipment)

4. Toys
(e.g., children’s toys, educational kits)

5. Personal Protective Equipment (PPE)
(e.g., safety helmets, gloves, face masks)

6. Construction Products
(e.g., cement, doors, windows, steel structures)

7. Pressure Equipment
(e.g., boilers, pressure cookers, gas cylinders)

8. Measuring Instruments
(e.g., water meters, gas meters, weighing instruments)

9. Gas Appliances
(e.g., gas stoves, heaters)

10. Radio and Telecommunications Equipment
(e.g., smartphones, wireless routers)

Each of these product categories must meet specific EU directives and undergo the appropriate CE Certification process before being sold in the EU market.

Steps to achieve CE marking:

To achieve CE Marking, follow these key steps to ensure your product complies with EU regulations:

Identify the applicable Directive(s)

The first step is to identify whether your product can be CE marked or not. Not all products are required to be CE Marked; only the products that fall within the scope of at least one of the CE Marking Directives. There are more than 20 product Directives & Regulations covering a range of products. Such products include (but are not limited to) electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices, and construction products.

Identifying which Legislation may be applicable involves a simple exercise of reading the scope of each Directive/Regulation. You then need to apply the scope to your product to establish which one applies. (An example of the scope of the Low Voltage Directive below). Don’t forget that there may be more than one Directive/Regulation that applies to your product! Remember, if your product does not fall within the scope of any of the CE marking Directives, then your product does not need to be CE marked, but is likely to fall within the scope of other product Directives (s).

Identify the applicable requirements of the Directive(s)

Each directive outlines specific methods to demonstrate conformity, which vary based on the product’s classification and intended use. To begin with, every directive includes a set of ‘essential requirements’ that the product must fulfill. The most effective way to show compliance with these requirements is by following the relevant harmonized European Norms (hENs). These standards help manufacturers align their products with the essential requirements of applicable EU legislation. Although standards provide a presumption of conformity, their use remains voluntary in most cases. To identify suitable hENs, you can search the Official Journal on the European Commission’s website.

Need to identify an appropriate route to conformity

The CE Marking process is always a self-declaration process; however, you may need to involve a third party. This is set out in the ‘system of attestation’ and will vary between Directives. Some products (such as invasive medical devices or fire alarm systems) may, to some extent, have a mandatory requirement for some involvement of an authorized third party.

There are various attestation routes, which include:

  • An assessment of the product by the manufacturer.
  • An assessment of the product by the manufacturer, with additional requirements for mandatory factory production control audits to be carried out by a third party.
  • An assessment by a third party (e.g., EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party.
Assessment of the product’s conformity

When all of the requirements have been established, you need evidence that the product meets the essential requirements of the Directive(s). This usually involves some assessment and/or testing. It will often involve ensuring that the requirements of the applicable harmonised standard(s), which were identified in step 2, have been met.

Compile the technical documentation

Technical documentation relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development, and manufacture of the product. Technical documentation may also be known as the Technical File or Technical Construction File.

Technical documentation will usually include:

  • Technical description.
  • Drawings, circuit diagrams, and photos.
  • Bill of materials.
  • Specification and, where applicable, Declarations of Conformity for the critical components and materials used.
  • Details of any design calculations.
  • Test reports and/or assessments.
  • Instructions.
  • Copy of the Declaration.
  • Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA).

Make a Declaration and affix the CE Mark

When the manufacturer, importer, or authorized representative is satisfied that their product conforms to the applicable CE Certification / CE Marking Directives, they must complete a Declaration. Under most Directives, it is known as the EU Declaration of Conformity, but other terms exist. Such as the Declaration of Incorporation for partly completed machinery and the Declaration of Performance for construction products.

The requirements for the Declaration vary slightly, but will at least include:

  • Name and address of the manufacturer.
  • Details of the product (model, description, and serial number, where applicable).
  • List of CE Marking Directives and standards that have been applied.
  • A statement declaring that the product complies with all of the relevant requirements.
  • Signature, name, and position of the responsible person.
  • The date that the Declaration was signed.
  • Details of the authorized representative within the EEA (where applicable).
  • Additional Directive/standard specific requirements.

In all cases, except for the PPE Directive, all of the Directives can be declared on one Declaration. Once a Declaration has been completed, the final step is to affix the CE mark to the product. When this has been done and all of the other CE Marking requirements have been met, the product can then be legally placed on the EU market.