CE marking is a certification mark used to show that products meet specific health, safety, and environmental standards for items sold in the European Economic Area (EEA). The acronym “CE” stands for “Conformité Européene,” which means “European Conformity.” Basically, it’s a declaration by manufacturers that their products meet all the legal requirements for CE marking.
For certain products sold within the EEA, having the CE mark is a requirement. The great thing is that once a product has this mark, manufacturers can freely sell it throughout the EEA without needing to make any further changes. In this article, we’ll explore the meaning, full form, the bodies responsible for certification, the steps involved, and the various applications of CE marking.
CE Marking: What it Means
CE marking is a symbol you might have seen on various products, and it holds significant meaning. It indicates that the product has been thoroughly assessed and meets the safety requirements set by the European Union (EU). When a product carries the CE mark, it means that the manufacturer or importer has declared that it complies with all the legal requirements in the EU for that specific type of product.
The process behind getting the CE mark is not just a formality; it involves independent testing and certification to ensure that the product meets the EU’s rigorous safety, health, and environmental standards. Once a product is CE marked, it can be freely sold and distributed in any country within the EU and the European Economic Area (EEA).
In simple terms, CE marking is like a stamp of approval, assuring consumers and authorities that the product meets the EU’s safety, health, and environmental protection standards, and can be traded freely across the EU and EEA market.
Full form of CE marking
he full form of CE marking is “Conformité Européene,” which translates to “European Conformity” in English. It’s a certification mark used to show that a product has been thoroughly assessed and meets the safety standards required by the European Union (EU) for specific types of products.
For certain products, it’s mandatory to have the CE mark in order to legally place them on the market within the European Economic Area (EEA). When you see the CE mark on a product, it means that it has undergone independent testing and certification to ensure it meets the EU’s stringent safety, health, and environmental standards. Moreover, it grants the product the right to be legally sold and distributed in any country within the EEA and EU.
Requirements for CE marking
The CE marking is required for various products falling under specific EU legislation, including items like construction products, medical devices, machinery, electrical equipment, personal protective equipment, toys, and more. To obtain the CE mark, manufacturers must comply with the EU’s harmonized standards for their products and conduct the necessary conformity assessments to demonstrate that their products meet the required levels of safety, health, and environmental performance.
Besides being a legal requirement, CE marking is also crucial for commercial purposes, as it assures consumers of the product’s safety and quality. Additionally, in some cases, having the CE mark is essential for participating in certain public procurement tenders.
Exceptions to CE Marking Requirements
Not all products sold within the European Economic Area (EEA) are required to have CE marking. There are some cases where CE marking is not mandatory, and the manufacturers do not need to go through the process of obtaining the CE mark for these products.
Some examples of products that do not require CE marking are:
- Products that are not covered by any EU Directive or Regulation that mandates CE marking.
- Custom-made products that are not intended for commercial distribution.
- Products that are meant for export only and are not placed on the EU market.
- Services that are provided rather than tangible goods.
- Products that are considered to be a minor part of a larger assembly and play a subsidiary role.
Additionally, we should be be aware that some products might be exempt from specific aspects of the relevant EU Directives. In such cases, the manufacturer may still need to obtain CE marking, but only for the parts of the product that fall within the scope of the Directive.
To determine whether CE marking is required or not, it’s necessary to refer to the relevant EU Directives and Regulations that apply to the specific product. Each product category may have its own set of rules, so it’s important to do proper research and seek guidance if needed.
List of Notified bodies for CE marking
A list of organizations known as “Notified Bodies” that play a vital role in the CE marking process have been mentioned below:
- TÜV SÜD
- Bureau Veritas
- UL (Underwriters Laboratories)
- SGS (Société Générale de Surveillance)
- Intertek
- Lloyd’s Register
- DEKRA
- BSI (British Standards Institution)
- TÜV Rheinland
Notified bodies are independent entities authorized by the European Union (EU) to assess and certify products for CE marking. They conduct conformity assessments on behalf of the EU and provide the necessary certificates or test reports to enable manufacturers to obtain CE marking for their products.
It’s important to note that each notified body may have specific areas of accreditation, and not all of them can assess and certify every type of product for CE marking. Manufacturers should refer to the list of notified bodies on the EU website and choose one that is accredited for their specific product and the corresponding EU Directive or Regulation.
Moreover, manufacturers often consider the location of the notified body in relation to their own manufacturing facility when making their selection. Working with a notified body in the same country or region can sometimes be preferred for convenience and logistics.
Steps for CE marking
Getting CE marking for a product involves several important steps, and the process may vary depending on the specific EU Directive or Regulation that applies to the product. Here’s a general overview of the steps:
- Identify Applicable EU Directives/Regulations: The first step is to determine which EU Directives or Regulations are relevant to the product. Each one has its own requirements that must be met.
- Choose Conformity Assessment Route: Depending on the product and the applicable Directive or Regulation, there might be different ways to demonstrate conformity. Manufacturers need to select the appropriate route for their product.
- Conduct Conformity Assessment: The manufacturer must perform the necessary assessments to show that the product meets the required safety, health, and environmental standards. This might involve testing, inspections, or a combination of both.
- Prepare Technical Documentation: A detailed technical file or documentation should be prepared. It must contain all the necessary information to prove the product’s compliance. This includes test reports, declarations of conformity, and instructions for use.
- Obtain CE Marking Certificate: Manufacturers need to seek certification from a notified body—an independent organization designated by the EU to assess and certify products for CE marking.
- Affix the CE Mark: Once the CE marking certificate is obtained, the manufacturer can apply the CE mark to the product and its packaging, as well as include it in the user manual or other documentation.
- Maintain Records and Be Ready for Market Surveillance: Records of the conformity assessment and technical documentation must be kept for at least 10 years. Manufacturers should also be prepared for market surveillance by the EU to ensure ongoing compliance.
It’s crucial to remember that the specific steps can vary depending on the product and the relevant EU Directive or Regulation. Manufacturers should refer to the specific guidelines for their product to ensure a smooth and successful CE marking process.
CE marking for medical devices
CE marking is mandatory for medical devices that are intended to be sold in the European Union (EU) and European Economic Area (EEA). To ensure the safety and performance of these devices, specific EU legislation, such as the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), has been put in place. Manufacturers must demonstrate compliance with the essential requirements of these regulations before placing their medical devices on the market.
The process of obtaining CE marking for medical devices involves a conformity assessment by a notified body—an independent organization authorized by the EU to assess and certify products for CE marking. Additionally, the manufacturer is required to create a technical file or documentation that provides all the necessary evidence to demonstrate the device’s adherence to the relevant requirements.
The conformity assessment procedure for medical devices varies depending on factors like the device’s class, its level of risk, and its intended use. Devices belonging to Class I, with the lowest risk, may often require self-declaration of compliance by the manufacturer. Conversely, Class III and implantable devices, with the highest risk, necessitate a more rigorous conformity assessment and continuous post-market surveillance by the manufacturer.
It’s essential to be aware that the EU’s Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) have recently come into effect in May 2020 and 2022, respectively. These regulations replace the previous Medical Device Directive (MDD) and In-Vitro Diagnostics Directive (IVDD), resulting in new rules and regulations being applied to medical device manufacturers.
Applications of CE Marking
CE marking finds widespread application across a diverse range of products that are made available in the European Union (EU) and European Economic Area (EEA). Its primary purpose is to signify that a product has undergone independent evaluation and complies with the relevant EU product safety legislation. Some key applications of CE marking include:
- Construction Products: CE marking is mandatory for construction materials and products covered by the Construction Products Regulation (CPR). This includes items like concrete, steel, timber, insulation, roofing, and flooring products.
- Machinery: CE marking is required for various types of machinery falling under the Machinery Directive. This category encompasses equipment such as cranes, lifts, conveyors, power tools, and other handheld machinery.
- Medical Devices: Medical devices must bear CE marking as per the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR). This applies to surgical instruments, diagnostic equipment, implantable devices, and more.
- Electrical Equipment: Electrical equipment falls under the scope of the Low Voltage Directive (LVD) and Electromagnetic Compatibility Directive (EMC). Products such as lighting, household appliances, and IT equipment require CE marking.
- Personal Protective Equipment (PPE): PPE, like safety helmets, goggles, and respirators, are subject to the PPE Regulation and need CE marking.
- Toys: Toys must have CE marking as per the Toy Safety Directive. This includes dolls, action figures, games, and other playthings.
- Recreational Craft: Recreational crafts, such as boats and yachts, are covered by the Recreational Craft Directive (RCD) and require CE marking.
- Gas Appliances: Gas appliances, such as heaters and stoves, must comply with the Gas Appliances Directive (GAD) and bear CE marking.
It’s important to keep in mind that this list is not exhaustive, and many other products also fall under the scope of CE marking. For instance, pressure equipment and explosives for civil use are among other items that require CE marking. To determine whether a specific product requires CE marking, it’s essential to refer to the relevant EU Directives and Regulations.
