The Manufacturers and Importers Guide to CE Marking Requirements

Since 1985, any product sold in the European Union must be CE-marked. CE is an acronym for Conformity European, which means “conformity with European legislation.” ” In other words, the product meets the requirements of EU regulations or EU directives, which qualifies the product for sale throughout the European Union each of the member states of the European Union has its laws and regulations relating to trade. These differences make it a challenge for manufacturers to market their products in each of the countries

A directive describes a legal act issued by the EU that requires member states to achieve a specific outcome. The directives do not dictate to member states how to achieve this result. In comparison, regulations are self-executing, which does not require implementing measures. Typically, directives provide latitude as to which regulation to adopt. Depending on the issue, legislators adopt guidelines using a series of legislative procedures and manoeuvres to achieve the desired result.

The process of issuing a new directive begins with the formulation of a proposed directive by the Marshal of Business, the European Commission and the Advisory Commission. The European Council of Ministers decides Whether to adopt the directive. If the ministry decides to make the amendment definitive, member states have a responsibility to append the directive's new requirements into their national legislation within two years.

The period between the directive proposal and adoption is called the transitional phase. During this period, member states may change or enact national laws to avoid duplicate and contradictory legislation, and national laws cannot be stringent. The directive becomes binding after the expiration of the transitional period.

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

Application of the best security practices regarding the product
Makes the directives tangible
Achieves a presumption of conformity by implementation of the directives requirements

The assimilation of the directive's requirements into the product also allows companies to have the maximum accumulation of legal burden of proof.

What is CE Marking?

The primary purpose of the CE marking is to help the free trade of products within EU and to minimize the effect of the physical borders between the member states. Another aim of CE marking has to do with making the legal criteria for safety health and the environment uniform across the EEA. The concern for safety applies to the workplace as well as safeguarding the public interests.

CE marking typically involves the following requirements:

Conduct a risk analysis for the product. This method determines the existence of any hazards, the extent of any risks to people, animals, property or the environment. It conjointly involves determining what solutions the product manufacturer can apply to minimize risk and remain in compliance with the acceptable law.

Provide an instruction manual in the user's language. & The manual must state the purpose of the product and any prohibitions and warnings. It should also contain instructions for maintenance and simple control

Draft and sign the EU Declaration of Conformity. The manufacturer or importer into the EEA makes a declaration that the product meets specific directives or regulations and standards.

Prepare technical documentation. This procedure includes the incorporation of the documents mentioned above, as well as any design data, drawings, calculations and test reports The technical documentation demonstrates that the product meets the basic requirements described in the applicable directive(s).

Adhere to the same requirements for imported products into the EEA market.Vendors and other parties must also comply with the sections of the directives that apply to them, including designers, distributors, retailers, suppliers, employers, and users.

In cooperation with the European Commission, public authorities within EU Member States have the responsibility to supervise 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 list or nomenclature of products they can rely on to indicate which CE marking directives apply. However, the CE marking refers to products put into service or for sale on the market in the EEA.

To find out whether a product needs to be CE certified, management must decide the countries where it will place its products and determine which directives affect the products

The following ratings can help you determine where your product fits in:

Construction Products – This category includes products manufactured for permanent incorporation into any construction work, which includes buildings and infrastructure (civil engineering).
Electromagnetic Compatibility– These types of products include virtually all electrical and electronic appliances, equipment and appliances that can cause electromagnetic disturbances or have their performance affected by such disturbances.
Gas Appliances– Appliances used for heating, cooking, hot water production, lighting, refrigeration or washing, which burn gas or other fuels, must also bear CE markings. This requirement does not apply to appliances whose water temperature does not exceed 105° or appliances designed for industrial applications.
Low Voltage– Electrical equipment rated between 50 and 1000 AC (alternating current) and between 75 and 1500 volts DC (direct current) must be CE marked.
Machinery– This category covers machines or appliances that have mechanically linked components or parts. A minimum of one component must be driven by a combination of actuators, controls and power circuits that work in unison for a given application. This class also applies to a set of interchangeable machines and equipment, which modifies the function of a machine. In addition, this category includes safety components for machinery and has exceptions that manufacturers and importers should consider.
Medical Devices– The medical devices category encompasses single-use products and non-automated scales. Does not include in vitro diagnostics or active implantable medical devices.
Instruments– This category includes a variety of devices that require operator assistance during weighing, including store scales, scales, platform machines, and scales, and which determine taxes, bonuses, tolls, and tariffs. It also includes provisions for law enforcement, health monitoring, and drug preparation in pharmacies.
Personal Protective Equipment– This classification includes appliances or devices designed for personal use that provide protection from safety or health hazards. Products range from cricket pads to safety helmets.
Pressure Equipment– The directive on pressure equipment and sets applies to devices that have an internal pressure greater than 0.5 bar. This category includes vessels, heat exchangers, pressurized storage vessels, industrial piping and fittings, and hull and water tube boilers
Recreational Vessel– Includes vessels intended for leisure and sports activities, regardless of the propulsion system. It also includes boats with a hull length between 2.5 and 24 meters and partially completed recreational vessels and components.
Simple Pressure Vessels– Refers to welded vessels made of aluminium or metal and designed to contain nitrogen or air under pressure, 30 bar or less. This classification includes reservoirs for airends as well as automotive and rail braking systems.
Toys– Most toys, clearly intended for play use by children under 14, fall into this category.

If you plan to sell any of the above products, you will need to apply a CE marking.

What Are the Benefits and Disadvantages of CE Marking?

The main reason why you should have CE marking on your product concerns the ability to gain access to the EEE. When European product directives apply to your products and you want to access that specific market, you must obtain mandatory CE marking to facilitate successful placement of products. Once you have secured CE marking, you only have to deal with a set of laws and regulations to comply with the design and manufacture of your product for the entire EU market.

CE marking eliminates the worry of multiple competing jurisdictional regulations covering your products. Plus, you add another level of security for consumers and other end users, which reduce damage claims and insurance premiums.

At times, directives may exceed existing member state laws and regulations. In some cases, you will need to change the design or manufacturing process to continue doing business or enter the EEA market.

Depending on the changes, you may incur additional costs to receive product certification and perform the necessary tests. You must understand the requirements implementation guidelines and nuances. Many companies find this aspect confusing because guidelines change consistently and are often subject to interpretation.

What is the CE Marking Process?

Placing the CE marking on a product means that the manufacturer declares that the product meets the basic requirements set out in all directives that apply to the product. The CE marking means to the competent authority that the product meets the legal requirements for sale in the member country. The CE marking represents the only symbol of compliance with these requirements.

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

The requirement for CE marking varies between directives as well as for the different products covered by a directive. For example, for some products, the directive may require a technical file, while other products may require the manufacturer to submit the item for recurring testing, which must be completed by an independent party. System assessment and a technical file may be required for some products during third-party testing, but the manufacturer's unconfirmed claim may be sufficient for other products.

The company or person placing products on the market within the limits of the EEA is responsible for complying with the directives and the CE marking, which may include the following entities or individuals:

Manufacturer – For manufacturers located in the EEA, the company has a full CE marking obligation. This level of responsibility also applies to an importer or manufacturer within the plenipotentiary established by the community of products or goods from companies located outside the boundaries of the EEA

Community established plenipotentiary – This person is appointed by the manufacturer and takes responsibility for certain tasks, such as signing the EC Declaration of Conformity or affixing the name and address to the nameplate. In this case, the importer assumes the authorization as if he were the manufacturer.

Importer of products – This person or company has full responsibility for placing the CE marking for products outside the EEA, even if they do not have direct authorization from the manufacturer. The trading company has complete responsibility for the CE marking if it meets the follow definitions of a manufacturer:

The trading company has complete responsibility for the CE marking if it meets the follow definitions of a manufacturer:

Assembles the product
Modifies or expands the product that results in a change in safety
Imports the product from a non-EEA country
Sells the product under its name or private label

When selling the product with its own brand, the seller must apply the necessary data to the product, draw up its CE declaration of conformity and change the personal data in the user manual. However, the initial concept must contain supplier data.

Documentation for CE Marking Compliance

You must demonstrate that your product complies with the directives in the event that an enforcement agency disputes your compliance with the directives. To provide evidence of compliance for your products, complete the required CE-mark certification or testing and have backup documentation on file. Keep in mind that each product may have other components that require compliance with different standards and regulations

For products that require CE Mark certification, create a specific technical file that contains the following information:

General Product Description
Information on how to operate the product
Design and fabrication drawings, including schematics of parts and subassemblies
A list of applicable harmonized standards, as specified by British
Institution of Standards in the United Kingdom
A description of the methods used to meet the essential requirements of each product
Directives that apply to the product
The result of any design calculations
Test reports from the supplier or those you have ordered from an independent testing body

Regulations require you to keep technical files for 10 years after production ends. At any time, an agency in the UK or any of the EU member states that has responsibility for monitoring product compliance can audit the product file. You will also use the files to demonstrate to potential customers that your product complies with the law.

How Can ECINT Assist You With CE Marking?

If a directive requires your product or system to undergo independent CE-mark testing, certification, or CE-mark inspection, you will need to obtain the services of a notified, competent, or approved body. This means that a member state “notified” this company to the European Commission.

From CE marking certification to CE marking testing or self-certification to accurate reporting, ECINT has over years of experience that will be invaluable for the challenges ahead. We can help get your products to market quickly and efficiently. To request a quote for CE marking, testing or other services, please feel free to contact us at info@ecint.co.in. One of our representatives will contact you soon. If you have any further questions about CE mark requirements, please let us know.