Manufacturers, importers, and retailers intending to sell electrical or electronic products in the European Union must have the CE marking. It is a mark of certification that the product has met the requirements necessary for ensuring health and safety, as per the directives in action.
Though this mark is not a quality label or mark itself, it is one of the critical legal requirements that need to have been obtained before the products are sold within the EU. CE marking is a tool that is employed in the harmonizing of the regulations and providing the same, usual standard against product safety and protection of the health and environment.
It also ensures free movement of goods within the markets of the European Union while making sure that the products being sold in Europe strictly match the level of safe protection standards that is being maintained.
What is CE Marking?
The CE marking is a sign that the product has passed a certification process showing that it complies with EU health, safety, and environmental protection laws. To put it in basic terms, the CE mark indicates that the manufacturer or shipper has checked through testing that their products meet the relevant EU directives.
CE mark, in full, is a derivation of Conformité Européenne, which literally means Conformity-European. (European Conformity) indicates that a product satisfies the provisions of the relevant Directives and can legally be sold in the EU.
Putting the CE mark on products calls for a manufacturer or the importer to demonstrate that the product satisfies the requirements of the applicable Directives. These vary from one product to the other, although most of them address critical health and safety aspects.
The process of the CE marking stipulates that the manufacturer or importer has to have a technical file drawn that describes the product. This technical file should have all the information relevant to the design, operation of the commercialized product, and the production of the product.
It should also specify the particulars of testing as well as conformity assessment activities performed by the manufacturer or importer. The manufacturer or the importer has to go through a conformity assessment procedure, an attempt to ascertain that the design, properties, and in-service performances of the product conform to the set community goals and principles envisioned in the relevant EU directives.
Products That Must Have CE Marking
Any electrical and electronic product sold within the European Union has to have CE marking. Examples of product types that bear CE marking are given below:
- Household appliances: washing machines, refrigerators, vacuum cleaners
- Toy and other children’s products: prams, cots, highchairs
- Electrical equipment: switches, motors, transformers
- Motor vehicles such as cars, motorbikes, and buses
- IT and telecommunications equipment: computers, printers, phones
- Industrial equipment: manufacturing and lift machinery
- Medical devices: surgical instruments and diagnostic apparatuses
- Radio and telecommunication equipment: mobile phones and broadcasting systems
- Construction materials: doors, windows, and structural steelwork
- Personal care and beauty products: hair dryers and shavers
- Electrical equipment for kitchens: oven, cooker, and toaster
Safety appliances and tools: fire alarms and extinguishers, smoke detectors, and lighting systems
The Legal Framework Behind CE Marking
The CE marking indicates the product’s conformance with EU standards for safety, health, and environmental protection. It gives permission for its lawful selling within the European Economic Area (EEA).
EU Directives and Regulations
Several of the key EU directives and regulations make up a large portion of the legal framework relating to the CE marking process. Directives, such as the Machinery Directive and Low Voltage Directive, mandate that products have the CE marking to be placed on the market in the EEA. For example, the Machinery Directive applies to industries to ensure the equipment used in manufacturing conforms to the essential health and safety requirements.
The Low Voltage Directive, on the other hand, deals with electrical equipment that falls within particular voltage ranges; it assures protection against electric shock and fire. These directives apply both to small and large-scale products across different industries, whereby only such products that pass these directives can be marketed and used within the EEA.
Harmonized Standards
Harmonized standards play a very key role in the process of compliance with EU directives. Such standards, in detail, provide technical specifications that, when followed, allow a manufacturer to meet the essential requirements of the directive.
Following harmonized standards will simplify the CE marking process for manufacturers since products that have been designed and tested against these standards are presumed to comply with the applicable directives.
Such an approach simplifies access to the market and aligns both small and large products to meet homogeneous safety and performance criteria in the EEA. Standards at national standards bodies are accessible, and any manufacturer can get them and use them as a reliable guide towards achieving CE compliance.
The Process of CE Marking
The process of CE marking involves ensuring that products adhere to the essential health, safety, and environmental standards of the EU. It includes the following steps:
- Determining applicable directives
- Conformity assessment
- Technical documentation
- Declaration of conformity
Determining Applicable Directives
The manufacturer should identify relevant EU directives for his product. Some of the common directives include the Machinery Directive, Low Voltage Directive, and the Electromagnetic Compatibility Directive. Each directive details its requirements in terms of safety, performance, and the environment.
Conformity Assessment
The manufacturers comply with the conformity assessment procedures in order to indicate that products conform to the requirements of applicable directives. On low-risk products, the manufacturer may perform a self-assessment. For high-risk products, the assessment shall be performed by a notified body. Notified bodies test, inspect, and certify for compliance.
Technical Documentation
Technical documentation plays a very important role in the process of CE marking. It basically consists of design specifications, risk assessments, and test results. Manufacturers should be in a position to prepare and keep proper technical files. Such files offer clear proof of compliance with EU directives and serve as support for the CE marking.
Declaration of Conformity
The EU Declaration of Conformity is an obligatory document in the process of CE marking, stating that a product complies with all the relevant applied directives. Therefore, at the time of drafting this document, one should be very careful in mentioning the followed directives and standards. This declaration shall be finally required to affix the CE mark and sell the product legally within the European Economic Area.
CE Marking in Mold Design and Mold Manufacturing
CE marking in mold and manufacturing cannot be underestimated. It is what makes sure that all products necessary undergo the test of essential safety and regulatory requirements set out for them.
For instance, at the stage of mold design, engineers have to consider material safety, structure strength, and compliance with EU directives. This makes sure that the final product will comply with all the health, safety, and environmental requirements.
Under the CE marking on mold manufacturing, it is imposed that strict quality control has to be followed to attain homogeneous and reliable production. Compliance elements should therefore be embedded with provisions on risk assessments and technical documentation in a process leading to obtaining certification under CE.
In a case study, Harry West Ltd is a manufacturer of farm machinery looking to address some of their product safety and legislation requirements. The CE Marking Association helped take them through the conformity process. This case study elaborates how CE marking is going to help manufacturers sidestep costly compliance issues and ensure access to the market within the EEA
