Guide with information on CE marking requirements | NTS (2023)

Guidance on CE marking requirements

Since 1985, every product sold in the EU must bear the CE mark. CE is an acronym for Conformité Européenne, which means "In accordance with European legislation". In other words, the product meets the requirements of EU directives or EU regulations, which qualifies it for sale throughout the EU. Each member state of the European Union has its own trade-related laws and regulations . These jurisdictional differences make it a challenge for manufacturers to sell their products in each country.

CE marking requirements could affect 50% of goods currently exported from the United States to the European Union (EU). Some products only require a self-declaration process, which allows the manufacturer to test their products and use factory manufacturing quality control to meet compliance requirements.

A directive describes a legal act issued by the EU that requires member states to achieve a specific result. The directives do not tell Member States how to achieve this result. By comparison, rules are self-enforcing and do not require enforcement measures. Directives usually provide discretionary power to decide which regulation to adopt. Depending on the issue, legislators issue directives using a range of legislative processes and maneuvers to achieve the desired result.

The process of issuing a new directive begins with the formulation of a proposal for a directive by the entrepreneur, the European Commission and the advisory committee. The European Council of Ministers decides whether the directive will be adopted. If the ministry decides to make the change final, member states are responsible for adding the directive's new requirements into their national legislation within two years.

The period between the proposed directive and its adoption is called the transitional phase. During this period, Member States can amend or adopt national laws to avoid duplicate and conflicting laws, and national laws cannot be made stricter. The directive becomes binding after the end of the transition period.

The directives provide guidelines on key criteria relating to health, safety and the environment as well as consumer protection for the trade of products within the European Economic Area (EEA). The guidelines provide a starting point. When manufacturers apply harmonized standards to their product, even when it is not mandatory, they realize many advantages:

• Implement product security best practices
• Make instructions tangible
• By applying the requirements of the directive, a presumption of conformity is obtained

Assimilation of the directive's requirements into the product also allows companies to maximize the accumulation of the legal burden of proof.

What is the CE mark?

The primary purpose of CE marking is to assist the free trade of products within the EU and to reduce the impact of physical borders between member states. Another purpose of CE marking is to harmonize legal criteria for safety, health and the environment across the EEA. Safety issues apply to the workplace as well as protecting the public interest.

There are more than 20 directives containing CE marking requirements. Each Member State is committed to incorporating the requirements into its national regulatory framework.

CE marking usually includes the following requirements:

Perform a risk analysis for the product.This process determines the existence of a hazard, the extent of the hazard to people, animals, goods or the environment. It also includes defining the solutions that the product manufacturer can use to reduce risk and maintain compliance with relevant legislation.

Provide instructions for use in the user's language.The purpose of the product and all prohibitions and warnings must be stated in the manual. It should also contain instructions for easy inspection and maintenance.

Prepare and sign the EU declaration of conformity.The manufacturer or importer for the EEA provides a declaration that the product meets specific directives or regulations and standards.

Prepare technical documentation.This process includes the inclusion of the above documents as well as all design data, drawings, calculations and test reports. The technical documentation shows that the product meets the basic requirements as described in the applicable directives.

Follow the same requirements for products entering the EEA market.Suppliers and other parties must also comply with the sections of the Directive that apply to them, including designers, distributors, retailers, suppliers, employers and users.

In cooperation with the European Commission, the public authorities of the EU member states are responsible for overseeing the CE marking process.

What types of products require CE marking?

Even with all the directives and regulations in place, manufacturers do not have a definitive product list or nomenclature they can rely on to indicate which CE marking directives apply. However, the CE marking applies to products used or sold on the market in the EEA.

To determine whether a product should receive a CE certificate, management must decide in which countries it wants to make its products available and determine which directives affect the products.

The following classifications can help you determine where your product fits:

• building materials– This category includes products manufactured for permanent installation in any construction work involving buildings and infrastructure (low-rise construction). CE marking for construction products is optional for products sold in the UK, Sweden, Portugal and Ireland, but many other Member States may require CE marking.
• Electromagnetic compatibility– These types of products include almost all electrical and electronic appliances, equipment and devices that may cause electromagnetic interference or whose performance may be affected by such interference.
• Gas appliance- Appliances for heating, cooking, preparing hot water, lighting, cooling or washing, which use gas or other fuels, must also carry the CE mark. This requirement does not apply to appliances whose water temperature does not exceed 105°C or to appliances intended for industrial use.
• Low voltage- Electrical equipment with a nominal voltage between 50 and 1000 AC (alternating current) and between 75 and 1500 volts DC (direct current) must bear the CE mark.
• Machinery– This category covers machines or devices that have mechanically connected parts or components. At least one component must be powered by a combination of actuators, controls, and circuits that work in concert for a specific application. This category also covers engine assemblies and interchangeable equipment that change the operation of the machine. In addition, this category includes safety components for machinery and has exceptions that manufacturers and importers must be aware of.
• Medical equipment– The medical equipment category includes disposable products and manual scales. Does not include in vitro diagnostics or active implantable medical devices.
• instruments– This category includes various devices that require operator assistance during weighing, including sales scales, scales, platform machines and bridge scales, and which determine taxes, bonuses, tolls and tariffs. It also includes law enforcement, health surveillance and pharmacy drug preparation units.
• Personal protective equipment– This classification includes devices or devices designed for personal carriage that provide protection against safety or health hazards. Products range from cricket pads to safety helmets.
• Pressure equipment– The Pressure Equipment and Devices Directive applies to devices that have an internal pressure greater than 0.5 bar. This category includes tanks, heat exchangers, pressure storage vessels, industrial pipes and fittings, as well as shell boilers and water pipes.
• Crafts for free time– This includes planning for recreational and sporting activities, regardless of the drive system. It also includes boats with a hull length between 2.5 and 24 meters and partially completed pleasure boats and accessories.
• A simple three-player game– This applies to containers that are welded and made of aluminum or metal and are designed to contain nitrogen or air under pressure of 30 bar or less. This classification includes reservoirs for compressor units as well as brake systems for automobiles and railways.
• Game- Most games clearly intended for children under 14 will fit into this category.

If you intend to sell any of the above products, you must affix the CE mark.

What are the advantages and disadvantages of the CE mark?

The most important reason to have a CE mark on your product is to access the EEA. When European product directives apply to your products and you want to access that market, you need to obtain the mandatory CE marking to facilitate successful product placement. Once you have secured the CE mark, you will only have to deal with one set of laws and regulations to comply with in designing and manufacturing your product for the entire EU market.

CE marking eliminates your need to worry about multiple competing regulations covering your products. Plus, you add another layer of security for consumers and other end users, which lowers claims and premiums.

Sometimes the directives may go beyond existing member states' laws and regulations. In some cases, you will need to change your design or manufacturing process to continue doing business or enter the EEA market.

Depending on the changes, you may incur additional costs to obtain product certification and perform any necessary testing. You need to understand the guidelines and nuances of implementing the request. Many companies find this aspect confusing as the guidelines are constantly changing and are often open to interpretation.

What is the CE marking process?

Placing the CE mark on a product means that the manufacturer declares that the product meets the essential requirements set out in all directives applicable to the product. The CE mark means to the competent authority that the product meets the legal requirements for sale in the Member State. The CE mark is the only symbol of compliance with these requirements.

Although the product may have additional markings, they do not carry the same weight as the CE marking. Other markings cannot cause confusion with the CE marking and must not interfere with the legibility and visibility of the CE marking.

The CE marking requirement varies from directive to directive and for different products covered by the directive. For some products, the directive may, for example, require a technical file, while other products may require the manufacturer to subject the item to periodic testing by an independent party. System evaluation and technical documentation may be mandatory for some products during third-party testing, but an unverified manufacturer's claim may be sufficient for other products.

A company or person placing products on the market within the borders of the EEA is responsible for compliance with the directives and CE marking and may include the following entities or persons:

Manufacturer– For manufacturers within the EEA, the company has a full obligation to mark with the CE mark. This level of responsibility also applies to the importer or manufacturer within the authorized representative of the Community of products or goods of companies located outside the borders of the EEA.

The community has created a proxy– This person is appointed by the manufacturer and takes responsibility for certain tasks, such as signing the EC declaration of conformity or placing the name and address on the identification plate. In this case, the importer takes over the license as if he were the manufacturer.

Importer of the product– This person or company has full responsibility for affixing the CE mark to products from countries outside the EEA, even if not directly authorized by the manufacturer.

A commercial company has full responsibility for CE marking if it meets the following manufacturer definitions:

• Collection of products
• Changes or extends the product resulting in a change in security
• Import the product from a country outside the EEA
• It sells the product under its own brand name or private label

When selling branded products, the seller must enter the necessary product data, draw up the EC declaration of conformity and change the personal data in the instructions for use. However, the original concept must contain vendor data.

CE marking documentation

You must demonstrate that your product complies with the Guidelines if the enforcement authority disputes its compliance with the Guidelines. To demonstrate the conformity of your products, you must complete the necessary CE marking certification or testing and have backup documentation on file. Remember that each product may have other components that require compliance with different standards and regulations.

For products that require CE marking, you must create a special technical file containing the following information:

1. General description of the product
2. Product handling information
3. Design and construction drawings, including schematics of parts and subassemblies
4. List of currently harmonized standards under British Standards
5. Model institution of the United Kingdom
6. Description of the methods used to meet the basic requirements for each product
7. Instructions applicable to the product
8. The result of any design budget
9. Test reports from suppliers or those you have ordered from an independent testing agency

Regulations require technical documentation to be kept for 10 years after the end of production. The UK or any EU Member State agency responsible for monitoring product conformity may revise the product file at any time. You can also use the records to prove to potential customers that your product complies with the law.

How can NTS help you with CE marking?

If the directive requires your product or system to undergo independent CE marking testing, certification or CE marking inspection, you must obtain the services of a notified, competent or approved body. This means that the Member State has "reported" this company to the European Commission.

From CE Mark certification to CE Mark testing or self-certification to accurate reporting, NTS has over 50 years of experience that will prove invaluable for the challenges ahead. We can help you bring your products to market quickly and efficiently. As a notified body, we can ensure you have the necessary expertise to work through the CE marking maze.

To request a quote for CE marking, testing or other services, please completeRequest for discountshape. One of our representatives will contact you shortly. If you have further questions about CE marking requirements,fill out the Ask an Expert form.

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