CE marking

CE marking’s impact upon user manuals

    CE-markering op verpakking en handleiding

    The European “New Approach” Directives are the basis for CE (Conformité Européenne) marking. According to these directives, products must meet certain requirements before being sold in the EU, with manuals playing a vital role in the regulatory process. In order to ensure that your product is able to be widely distributed within the EU, it’s important to know what the European New Approach Directives mean, and exactly how they will impact you and the manuals of the products that you offer.

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    What are the European “New Approach” directives?

    In essence, the directives set forth a number of essential requirements regarding the safety, environmental impact, health, and consumer protection for products that are being bought and sold within the European Economic Area (which is commonly referred to as the EEA).  The directives, in many respects, form a basis for CE Marking. The requirements mentioned above apply to a variety of different products, from medical devices to toys, each of which must adhere to strict manufacturing standards.

    The directives, themselves, are developed by the European Commission, the business marshal, or the Advisory Commission, who will propose a new directive. It is then passed onto The European Council of Ministers, who will decide whether or not the directive is to be formally adopted. If the process is successful and the directive is formally adopted by the European Council of Ministers, the member states are then obligated to integrate the new requirements introduced by the directive into their legislation. Typically, this must be done within a specific time period, which is usually two years.

    The time between when the directive is approved and when it is entered into legislation is known as the “transitional phase”. After this phase, the directive is legally binding and, as a general rule, cannot be amended or added to once it has been passed into legislation. For example, the member states would not be able to formalize any additional requirements regarding the directive. Quite often this leads to laws that must be changed at a later date in order to alter directive specifications or to avoid redundant laws.

    To explain how the essential requirements can be fully adhered to, on a technical level, standards are being developed throughout the EU. When a manufacturer chooses to utilize these standards voluntarily, they can expect the following benefits:

    • Gain the ability to utilize the latest technology in order to manufacture safe products
    • Adhere to the “presumption of conformity”, which allows them to ensure that they are meeting the requirements set forth by the directives. This also helps to build up a legal defense, in the event that a burden of proof is necessary.
    • Helps to make the directives more concrete and raises the overall health and environmental safety standards within their industry.

    Who is responsible for applying the CE Mark?

    The individual or business entity who offers the products within the European market is responsible for ensuring that the product meets compliance standards set forth by the directive. These individuals or entities could be:

    • The manufacturer of the item. If the manufacturer is based within the EEA, then they are responsible for obtaining the CE mark. However, if the manufacturer is located outside of the EEA, the importer of the product or the ‘In the Community Established Plenipotentiary’ is generally responsible for the CE mark.
    • The ‘In the Community Established Plenipotentiary’, who is typically appointed by the manufacturer and is responsible for certain tasks. For instance, they might be in charge of obtaining the CE Mark itself by signing the “declaration of conformity”,  or may be tasked with applying the sticker to the product. Under these circumstances, the importer has been authorized to act as the manufacturer, legally speaking.
    • An importer of products that originated from outside the EEA. They are held responsible for placing the CE mark on the product, even if they have not been officially authorized by the actual manufacturer of the goods.

    In the case of a trading company, the CE Mark is only their obligation when they are seen as the manufacturer of the product.  If the following circumstances apply, then the trading company is obligated to obtain and place the CE mark:

    • Produces or assembles the goods at their facility
    • Alters the safety of the product by modifying or changing any aspect of the item
    • Sells or distributes the product under their own name or brand. In this instance, the new seller would be required to sign their own EC “declaration of conformity” and alter personal data within the manual.
    • Imports the product from a country that is not located within the EEA.

    Based upon the specifications of the Product Liability Law you are liable for your product. In the event that a product is purchased from a manufacturer located within the EEA, the “Liability Promise” can be passed onto the manufacturer. However, if the product is purchased outside of the EEA, then you will be held accountable and liable, given that you are acting as the ‘In the Community Established Plenipotentiary’.

    How to implement CE Marking for your product (As the Manufacturer)

    The manufacturer is required to carry out a number of steps in order to meet the essential requirements set forth by the directives. Here are the necessary steps that you, as a manufacturer, will need to perform to obtain a CE Mark for your product:

    1. Define the intended use and potential risks of your product.
    2. Determine which directives may pertain to your product. You can do this by checking to see if your product falls within the purview of other pre-existing directives.
    3. Carry out a thorough risk analysis and safety assessment by testing the product based upon the essential requirements. If problems are detected, then take steps to bring your product in adherence with European standards.
    4. Carry out the appropriate certification procedure (seek the assistance of a governmental or certification body, if necessary).
    5. Study the European standards and determine which apply to your product.
    6. Verify that the parts used to manufacture the product have adequate documentation and all necessary declarations.
    7. Verify that all contracts (including those regarding the procurement of parts) are complete. You also need to verify that each component has a an agreement pertaining to the the CE marking.
    8. Ensure that note of delivery contains all pertinent information, particularly in regards to the CE marking.
    9. Create a user manual for the product and translate it to the appropriate language (depending upon the countries in which the item will be distributed).
    10. Compile a Technical (Construction) File for the product and place in it in the archives.
    11. Develop a “Declaration of Conformity”, which must be signed upon completion.
    12. Place the CE Mark on the product (or packaging, if applicable).

    How to implement CE Marking for your product (As the trading company)

    Even if a trading company is not viewed as the manufacturer of the product, the entity must still adhere to certain guidelines and regulations. For example, it is still expected to handle certain responsibilities associated with the CE Marking. Here are the necessary steps that a trading company will need to perform to obtain a CE Mark for a product:

    1. Define the intended use and potential risks of your product.
    2. Determine which directives may pertain to your product. You can do this by checking to see if your product falls within the purview of other pre-existing directives.
    3. Verify that all purchase agreements are in order and that the necessary CE marking documentation has been provided.
    4. Verify that a user manual for the product has been provided, and that it has been translated to the appropriate language (depending upon the countries in which the item will be distributed).
    5. Ensure that you’ve received a “Declaration of Conformity”, which must be signed by the manufacturer.
    6. Verify that the CE marking has been applied to the product (or packaging, if applicable).

    Fundamental requirements of the European “New Approach” Directives

    As a general rule, the essential requirements often pertain to the technical safety standards of the product in question. These practical requirements can be found in Annex 1 of the European “New Approach” Directive, and must be adhered to in order to distribute your product within the EEA.

    To determine if your product meets the essential requirements, government inspectors will examine and assess the product to ensure that it is up to par with the current standards. Documentation and vital product information is also considered during the inspection process. This pertains to the product’s user manual, installation instructions, maintenance suggestions or recommendations, the “declaration of conformity” and the CE marking. These are all important aspects that are required in order to meet European standards. For instance, the “New Approach” directives stipulate that all products that are to be distributed within the EEA be accompanied by instructions for use. In fact, the EN 82079-1, which is a European conformity (or harmonized) standard, sets forth minimal requirements in regards to a product’s instructions for use.

    Self certification and Inspections

    More often than not, a manufacturer or trade company has the power to certify themselves. This is referred to as “self-certification”, and can be obtained by carrying out an internal manufacturing inspection. However, if the product is linked to a number of risk factors, such as an item that is typically not harmful to the environment, then an approved third-party inspection agency must be called in to carry out an assessment of the product.

    Manufacturing Parts and Purchase Agreements

    If the product has been assembled by you or your company and have utilized third-party parts, then you must also ensure that your parts supplier has adequate CE markings. In the event that the individuals parts are not required to having markings, then you must still ensure that the parts comply with the essential requirements. This is to verify that your finished product will also adhere to those specific requirements. Therefore, it is highly recommended that that you register the CE marking agreements withing a “repurchase agreement”, which should also explain how each task was handled during the manufacturing process. Here are some guidelines that you may want to follow when developing a “repurchase agreement”:

    • The manufacturer should compile a Technical (Construction) file and archive it.
    • Include the directive that the part or product must adhere to.
    • Determine if it is necessary to hire a third-party inspection agency to carry out the certification process.
    • Stipulate which standards the product or part meet (this is not necessarily mandatory, but recommended).

    The importance of the User manual

    A vast majority of products should include a user manual that explains how the product can be used safely, in order to meet consumer protection requirements. Also, the manual should offer instructions to the consumer (using easy to read language, rather than technical jargon), which will allow users and service people to maintain or repair the product. If your product is going to be offered solely to consumers, then a user manual is sufficient.

    It’s important to note that all potential hazards and risks must be mentioned in the user manual of the product. The dangers associated with improperly using the item should also be outlined. In order to adequate formulate these consumer warnings, manufacturers should be aware of essential requirements, have an understanding of the knowledge and experience level of the consumer, and properly test the product to determine potential risks.

    Here are possible user manual inclusions:

    1. Title page, name and type of the product (or code), trade name, and an image of the product
    2. Technical specifications and certification (also known as the “Declaration of Conformity”)
    3. References to other necessary documents or reference guides
    4. Table of contents, description of images, and necessary attachments
    5. Introduction to the manual, which indicates the purpose of the user manual
    6. General safety recommendations or requirements
    7. Detailed description of the item, which should include the materials used during the manufacturing process (parts, composition of the item, etc)
    8. Explanation of how the product should be used and how to install or adjust the product
    9. Description of all possible practical uses of the product
    10. Recommended or required maintenance and a sample maintenance schedule
    11. Description of how to properly store and transport the product (Does it need to be stored in cool environment? Is it best to use a specialized bag to carry the item?)
    12. Brief troubleshooting guide to remedy common issues (including repair options)
    13. Any recommended accessories that are associated with the product
    14. Description of how to dismantle the product
    15. Index
    16. Glossary
    17. Any necessary attachments

    Most of the “New Approach” directives dictate that user manuals must be translated into the language of the country where the product is being distributed or used. The individual or entity who imports the item into the country is held responsible for ensuring that the manual has been translated into the country’s specific language. This also applies to trading companies, given that the manufacturer is often unaware of which regions their products are being exported to by third parties (i.e. importers and trading companies).

    What must be included in the Technical (Construction) File

    A Technical (Construction) File consists of a detailed explanation of the product’s design and how to safely use the product.  This Technical File contains schematics, drawings, certifications, analysis reports, the user manual, component lists, and other vital information. This file must be retained by the manufacturer, who must present it to any notified body upon request. If the physical document it is not available at the time of the request, then it must be presented within a few weeks time. Technically, the documents must legally be retained for a period of 10 years after the initial manufacturing date of the product. However, if the product is part of a series, then the 10 year time frame starts when the last product within that series is produced. In some instances, the Technical File is a vital component of the conformity assessment. 

    The EC “declaration of conformity”

    For every product (or series of products) that falls under the purview of a European “New Approach” Directive,  an EC “Declaration of Conformity” must be created and signed.  This document indicates that the product meets all of the safety, health, and environmental requirements of the directive. If the product is associated with multiple different directives, then the product’s compliance can be indicated with just one EC “Declaration of Conformity”. However, it is essential that the manufacturer specify which notified body performed the inspection of the product, or which third party has carried out the quality evaluation. Once this is done, the declaration can then be signed by the manufacturer’s representative (an individual who is authorized to do so and who uses the language that is featured within the manual). In some case, the declaration must be sent along with the product, and a copy of the Technical File must be included. However, there are certain instances wherein the declaration can simply be retained by the manufacturer. This greatly depends upon which directive applies to the product itself.

    Application of the CE Mark

    The CE Marking can only be applied to a product when it meets all of the essential requirements that have been set forth by the European “New Approach” Directives. The CE Mark is usually added to the identification plate, the product’s label, or by placing a sticker on the product itself. However, in some cases, directives specify that the CE Marking can be placed on the packaging of the product.