Since 1985, any product sold in the European Union must bear the CE mark certification. CE is an acronym for Conformité Européenne, which means, “Conforms to European legislation.” In other words, the product meets the requirements of EU directives or EU regulations, which qualifies the product for sale throughout the European Union. Each of the member states within the European Union has its laws and regulations pertaining to commerce. These jurisdictional differences make it a challenge for manufacturers to market their products in each of the countries.
CE mark requirements may affect 50% of the goods currently exported from the United States to the European Union (EU). Some products require only a self-declaration process, which allows the manufacturer to test its products and use factory production quality control to meet compliance requirements.
A directive describes a legal act issued by the EU that requires member states to obtain a specific result. Directives do not dictate to the member states the manner in which to achieve that result. In comparison, regulations are self-executing, which does not require implementation measures. Typically, directives provide latitude as to the regulation to adopt. Depending on the subject matter, lawmakers adopt directives using an array of legislative procedures and maneuvers to achieve the desired result.
The process for issuing a new directive starts with the formulation of a proposed directive by the business marshal, 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 final, member states have the responsibility to append the new requirements in the directive in their national legislation within two years.
The period between the proposed-directive 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 more stringent. The directive becomes binding after the expiration of the transitional period.
The directives provide the guidance for the basic criteria relating to the health, safety, and environment and consumer protection for products trade within the European Economic Area (EEA). The directives provide a starting point. When manufacturers apply the harmonized standards to their product, even when it is not mandatory, they realize a number of advantages:
Assimilation of the directive requirements into the product also allows companies to have the maximum accumulation of legal burden of proof.
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.
There are more than 20 directives that contain CE marking requirements. Each member state has committed to the incorporation of the requirements into their national regulatory structure.
CE marking typically involves the following requirements:
Conduct a risk analysis for the product. This process determines the existence of any hazards, the extent of any risks to people, animals, goods or the environment. It also involves determining what solutions the product manufacturer can apply to minimize risk and remain in compliance with the appropriate law.
Provide an instruction manual in the language of the user. The manual must tell the intended purpose of the product and any prohibitions and warnings. It should also contain instructions for simple control and maintenance.
Draft and sign the EU declaration of conformity. The manufacturer or importer for the EEA makes a declaration that the product meets the 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 as outlined 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.
Even with all of the directives and regulations in place, manufacturers do not have a definitive product list or nomenclature that they can rely on to indicate which CE marking directive(s) apply. Nonetheless, the CE marking pertains to products placed in service or for sale in the market in the EEA.
To find out whether a product needs to be CE certified, management must decide on the countries where they will place their products and determine what directives(s) affect the products.
The following classifications can help you determine where your product fits:
If you plan to sell any of the above products, you will need to apply a CE marking.
The number one reason you should have the CE marking on your product concerns the ability to gain access to the EEA. When European product directives apply to your goods and you want access to that particular market, you must obtain the mandatory CE marking to facilitate the successful placement of the products. Once you secure the CE marking, you only have to deal with one set of laws and regulations to comply with the design and manufacturing of your product for the entire EU marketplace.
The CE marking eliminates your need for concern about numerous competing jurisdictional regulations covering your products. In addition, you add another level of safety for consumers and other end-users, which reduce damage claims and insurance premiums.
Sometimes the directives may exceed the existing member state laws and regulations. In some cases, you will need to change the design or manufacturing process in order to continue doing business or enter the EEA marketplace.
Depending on the changes, you may incur additional costs to receive the product certification and conduct any required testing. You must understand the directives and the nuances of implement the requirements. Many businesses find this aspect confusing because the directives undergo consistent change and often are subject to interpretation.
The placement of the CE marking on a product means that the manufacturer declares that the product complies with the basic requirements set forth in all of the directives, which apply to the product. The CE marking signifies to the appropriate authority that the product meets the legal requirements for sale in the member country. The CE marking represents the only symbol of compliance with those requirements.
Although a product may have additional markings, they do not have the same weight as the CE marking. Other markings cannot cause confusion with the CE marking and should not interfere with the legibility and visibility of the CE marking.
The requirement for CE marking varies across directives, as well as for the different products covered in a directive. For example, for some products the directive may necessitate a technical file while other products may require the manufacturer to submit the item for recurring testing, which an independent party must complete. System evaluation and a technical file may be mandatory for some products during third-party testing, but the manufacturers’ unconfirmed claim may suffice for other products.
The company or person who brings the products to market within the limits of the EEA has the responsibility for compliance with the directives and CE marking, and may include the following entities or individuals:
Manufacturer - For manufacturers located within the EEA, the company has the complete obligation for the CE marking. This level of responsibility also applies to an importer or manufacturer within the community’s established plenipotentiary of products or goods from companies located outside of the EEA boundaries.
Community established plenipotentiary - This person is appointed by the manufacturer and takes the responsibility for certain tasks, such as signing the EC Declaration of Conformity or affixing the name and address to the identification plate. In this instance, the importer assumes the authorization as if he or she is the manufacturer.
Importer of products - This person or company has complete responsibility for the placing of the CE marking for products from outside the EEA, even though he or she does 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:
When selling the product under a private label, the seller must apply the required data to the product, draw its EC declaration of conformity, and change the personal data in the user manual. However, the initial concept must contain the data of the supplier.
You must demonstrate that your product complies with the directives in the event an enforcement agency challenges its compliance with the directives. To provide evidence of compliance for your products, complete the required CE mark certification or testing, and have backup paperwork in the files. Keep in mind that each product can have other components that require compliance with different standards and regulations.
For products that require a CE mark certification, create a specific technical file that contains the following information:
The regulations require you to keep technical files for ten years after the production has ceased. At any time, an agency from the UK or any of the EU member states that have the responsibility to monitor product compliance could audit the product file. You can also use the files to demonstrate to potential customers that your product complies with the law.
If a directive requires your product or system to undergo independent CE mark testing, CE mark certification or inspection, you will need to obtain the services of a notiﬁed, competent or approved body. This means that a member state has “notified” this company to the European Commission.
From CE marking certification to CE marking testing or self-certification to accurate reporting, NTS has over 50 years of experience that will prove invaluable for the challenges that lie ahead. We can help get your products to market quickly and efficiently. As a notified body, we can ensure that you have the expertise needed to work through the CE marking maze.
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