Why is CE Certification Important?
CE certification confirms that the product entered the market legally, has all the permits, and does not pose any threat to human health or the safety and integrity of the environment. Thus, the CE mark signals both buyers and official regulators about the successful completion of all testing and certifying procedures.
What Countries Require CE Compliance?
The mandatory CE certification applies to products entering the market of all 30 countries of the European Economic Area (EEA). It also covers Switzerland and Turkey, the United Kingdom, which have signed a number of bilateral agreements with the EU, including the CE marking requirement. Additionally, the UK indefinitely recognizes the EU's CE mark for various manufactured goods placed on the UK market.
European Economic Area Countries
Republic of Cyprus
Which Products Need a CE Mark?
To determine whether a product requires CE certification, manufacturers should consult the relevant EU directives and harmonized standards. Notified bodies, independent organizations authorized to assess product compliance with EU directives, can also provide guidance.
Household appliances, power tools, lighting, cables
Dolls, action figures, toy cars, construction sets
Industrial machinery, agricultural machinery, construction machinery
Surgical instruments, implants, diagnostic equipment
Cement, steel, windows, doors
Personal protective equipment
Safety helmets, goggles, gloves, boots
Gas cylinders, boilers, pressure cookers
Cookers, heaters, gas water heaters
Spray paint, deodorants, insecticides
Mobile phones, routers, modems
Radios, televisions, Bluetooth devices
Escalators, elevators, dumbwaiters
Fireworks, detonators, ammunition
Products That May Be Sold Without a CE Mark
Not all products imported into the listed countries require CE marking certification. In particular, goods belonging to the following categories, which are covered by other Directives, are subject to a different type of certification:
How to Obtain CE Certification?
Obtaining a CE certificate involves a systematic process:
Identify Applicable Directives
The Directives include general safety requirements for products placed on the market. The specific parameters and technical requirements are detailed in the harmonized standards. If a product does not fall under any Directives requiring CE marking, it must still comply with a document outlining general safety requirements.
Low Voltage Directive (LVD)
Electromagnetic Compatibility (EMC)
Simple Pressure Vessels Directive
Ecodesign for Energy-related Products
Noise Emission for Outdoor Equipment
Regulation (EU) No 305/2011
Regulation (EU) 2016/425
Personal Protective Equipment
Non-automatic Weighing Instruments
Regulation (EU) 2016/426
Appliances Burning Gaseous Fuels
Explosives for Civil Uses
Regulation (EU) 2017/745
Active Implantable Medical Devices
In Vitro Diagnostic Medical Devices
Equipment and Protective Systems for Use in Explosive Atmospheres (ATEX)
Marine Equipment Directive
Regulation (EU) 2016/424
Cableway Installations to Carry Persons
Restriction of Hazardous Substances (RoHS)
Identify the requirements for the product
Each Directive specifies essential requirements that a product must meet. To demonstrate conformity, manufacturers must identify applicable 'harmonized European Norms' (hENs), which are standards that offer a presumption of conformity to the essential requirements. These standards vary depending on the product's classification and intended use. Harmonized standards, available on the European Commission’s website, simplify compliance through clear frameworks.
Determine if third-party assessment is needed
Certain directives may require third-party assessment by a Notified Body (NB), an organization authorized by European authorities. For example, the Medical Devices directive and others mandate the use of an NB. However, the EU has reduced the number of products requiring NB assessment, placing more responsibility on manufacturers.
Assess Product Conformity
Conduct a thorough assessment of your product to ensure it conforms to the essential requirements outlined in the relevant directives. This step may involve testing and verification processes to demonstrate that your product meets the necessary safety and environmental standards.
Compile a Technical File
Create a comprehensive technical file that documents every aspect of your product's design, development, and manufacturing process. This technical file, also known as the Technical Construction File, should include technical descriptions, drawings, circuit diagrams, bills of materials, specifications, test reports, and other relevant information. The file serves as evidence of conformity and must be maintained for up to 10 years after the last unit is manufactured.
MAKE A DECLARATION AND AFFIX THE CE MARK
When satisfied that the product conforms to the applicable CE Marking Directives, the manufacturer must complete a Declaration of Conformity. It includes information about the product, directives, standards applied, and the responsible party in the company.
Following this, affix the CE mark visibly on the product, signaling compliance with EU standards. This is the final stage, after which the product may be launched to the EU and EEA markets.
Responsibility of Manufacturers for CE Certification
To complete the standard procedure for obtaining the CE mark, manufacturers must find out which EU Directive regulates the access of products of their category to the market and check compliance with all regulations. After that, a conformity assessment is carried out, based on which a technical file is prepared. Further, the EU-authorized body examines the documents, and the manufacturer issues the EC Declaration of Conformity (DoC). When all documents are certified and the CE mark is received, the manufacturer can label with this mark their products and packaging.
Responsibility of Distributors for Products with a CE Mark
Distributors of goods in the EU market must ensure that the CE mark has not yet expired and that the certificate itself is not fake. They also check the placement of the stamp on the product or its packaging since marking is the responsibility of the manufacturer.
What is the Advantage of CE Certification?
There are several advantages to CE certification, including:
Free movement of goods within the EEA
Allows manufacturers to freely circulate their products within the EEA without facing additional technical barriers to trade.
Increased market access
CE certification can help manufacturers gain access to new markets in the EEA, as well as in other countries that recognize the CE marking.
Enhanced product safety
Helps to ensure that products meet high standards of safety and environmental protection.
Improved consumer confidence
CE certification indicates independent compliance with EU safety requirements, boosting consumer confidence.
Become CE Certified with 360Compliance
The CE marking procedure can be tedious and incomprehensible to non-professionals. However, the 360Compliance team will help you pass all stages of certification quickly, competently, and successfully. You will receive full project management with no hassle. You are also guaranteed technical support and a transparent pricing policy.
To start the testing & certification process for obtaining a CE stamp, contact the 360Compliance team in any convenient way and get all the answers and instantly initiate the certification procedure.
Frequently Asked Questions About CE Marking
For How Long is a CE Certificate Valid?
For each product group, a certain validity period is established, but in most cases, it is 3 years. After that, you need to go through the re-certification procedure. However, there are products for which the CE mark is valid for 10 years or more.
What are the Penalties for the Absence of a CE Certificate?
Punishment for selling goods without the certificates in countries where the CE marking is mandatory varies widely from administrative to criminal liability. The specific article of the law that will be applied depends on the damage that a given product can cause to people or the environment.
How to Get a CE Certificate?
To obtain the CE stamp, it is necessary to go through a risk assessment procedure for the products offered. For this, you need to study the standards of the specific Directive that regulates access to the market for this type of products, make up a technical file, and pass testing. When all permits are issued, CE marking can be applied to the offered products.
How to Authenticate a CE Certificate?
You can authenticate a CE mark using the official database. Also, it is possible to contact the official authority that issued the certificate and request details on this product. If it turns out that this product is not registered with official institutions, you are dealing with fake certification.