Product & CE Certification
European Union is currently a political and economic organization consisting of 28 member states with a total population of more than 500 million. One of the four basic freedoms granted by this union is the free movement of goods.
CE Marking signifies that the products meet all the requirements of the EU technical regulations and can be circulated among the member states of the EU without facing any technical barriers.
What is CE certificate?
We see capital letters CE on many products in free movement in the European Economic Area. This marking, meaning Conformity with Europe, demonstrate that the products have been audited/assessed in terms of minimum safety, health and environmental requirements. You would see CE marking on a new telephone, food processor, TV set or crayons purchased in the European Community. CE marking also indicates fair competition among manufacturers as it enforces accountability and conformity with the same requirements.
In nutshell as defined below
- Identify the Instruction (s) that are applicable to your product.
- Identify the compliance assessment procedure for your product and Instruction
- Determine the dates by which you must take action.
- Identify if there are any Harmonized European Standards applicable to your product.
- Ensure the product complies with all the essential requirements of the Instruction(s).
- Identify whether independent assessment of your compliance is required by a Notified Body
- Maintain Technical Documentation required by the Instruction(s).
- Prepare the Declaration of Conformity and the required supporting evidence.
- Check that no other purely national requirements exist in the country where the product is to be sold.
- Affix CE marking on your product and/or packaging.
What is the use of CE certificate?
A manufacturer who affixes CE marking to his products, declares that the products are in conformity with all necessary requirements (regulations and standards) and can be sold in the economic area. CE Certificate secures two great advantages for the business world and consumers. The business world acknowledges that products bearing CE marking can be sold in the European Economic Area without facing any barriers, and consumers feel assured that products they purchase meet all essential health, safety and environmental requirements. It is the manufacturer's responsibility to carry out conformity assessment of products, to prepare technical files, to acquire CE marking where necessary, to draw up EU Declaration of Conformity, and to affix CE marking to the products.
How to get CE certificate?
All conformity assessment procedures (modules) including testing, inspection and/or CE certification must be completed before the product is placed on the market. Manufacturers should confirm the regulations covering their products, and if necessary, should apply to notified bodies designated to give conformity assessment services.
What information should be included in the EU declaration of conformity?
The EU Declaration of Conformity should contain the following information related to the product, manufacturer or representative, notified body where applicable, and harmonised standards:
Unique identification of product,
Name and address of manufacturer or authorised representative,
Statement of sole responsibility of the manufacturer of this declaration,
Identification of product allowing traceability, clear product photograph where appropriate,
Relevant European Community directive,
References to the relevant harmonised standards and/or specifications,
Where applicable, the name and ID number of the notified body, description of the module and CE certificate information,
Additional information, signature, name and function of designated signatory, and place and date of issue.
How to affix CE marking to products?
The mark must take the form as seen in the below picture. The proportions must be respected even if the dimensions are changed. The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents.
Products that need CE marking
CE marking is mandatory, but only for those products which are covered by the scope of one or more of the New Approach Directives.
You can view the EC New Approach Directives guidance from the Europa website.
Even if your product is manufactured outside the EEA, you must ensure the product bears CE marking if your product comes under the scope of a directive requiring CE Marking. Not all products sold in the EU need to bear CE marking.
CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:
- active implantable medical devices
- appliances burning gaseous fuels
- cableway installations designed to carry persons
- eco-design of energy related products
- electromagnetic compatibility
- equipment and protective systems intended for use in potentially explosive atmospheres
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- low voltage
- measuring instruments
- medical devices
- noise emission in the environment
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- safety of toys
- simple pressure vessels
The CE marking is not required for items, for example:
We give CE Certification service for the following EU Directives
- low Voltage Directive for Electric Operational Products: 2014/35/EU
- Active Implantable Medical Devices: 90/385/EEC
- Simple Pressure Vessels: 2014/29/EU
- Toy Safety: 2009/48/EG
- Building materials: VO (EU) 305/2011
- Electromagnetic Compatibility (EMC): 2014/30/EU
- Personal Protective Equipment (PPE): 89/686/EEC (from 21.4.2018: VO (EU) 2016/425)
- Ecodesign requirements for energy-using products: 2005/32/EG
- Lifts: 2014/33/EU
- Medical Devices-93/42/EEC
- Electrical Equipment-2014/35/EU
- Construction Products-EU) NO 305/2011
- Appliances Burning Gaseous Fuels-2009/142/EC
- New Hot-Water Boilers-92/42/EEC
- Pressure Equipment-2014/68/EU
- Simple Pressure Vessels-2009/105/EC
CE Marking is a Certification mark that shows similarity with well being, security, and natural confirmation guidelines for things sold inside the European Economic Area. The CE Marking Certification is likewise found on items sold outside the EEA that are made in, or intended to be sold in, the EEA.
Benefits of CE Marking:
There are two fundamental advantages of CE Marking bring to organizations and consumers inside the EEA :
Businesses: realize that items bearing the CE Marking can be exchanged the EEA without limitations.
Consumers: appreciate a similar dimension of health, security, and ecological assurance all through the whole EEA.
Fulfills the necessities of important European item orders.
Meets every one of the necessities of the important perceived European fit execution and security standards.
Is fit for its motivation and won’t endanger lives or property.
The CE Marking will be appended uniquely by the maker or his approved agent.
The CE Marking will be appended uniquely to items to which its joining is accommodated by explicit Community harmonization Legislation, and will not be fastened to some other item.
By appending or having fastened the CE Marking Certification, the producer shows that he assumes liability for the congruity of the item with every appropriate prerequisite set out in the applicable Community harmonization legislation accommodating its joining.
The CE Marking Certification will be the main checking which authenticates the congruity of the item with the pertinent necessities of the applicable Community harmonization enactment accommodating its joining.
Member States will guarantee the right execution of the routine administering the CE Marking and make fitting move in case of ill-advised utilization of the stamping. Part States will likewise accommodate punishments for encroachments, which may incorporate criminal authorizations for genuine encroachments. Those punishments will be proportionate to the reality of the offense and establish a viable hindrance against ill-advised use.
The Kitemark is a voluntary, independent third-party mark that offers peace of mind for both the consumer and the specifier.
To achieve Kitemark certification requires a manufacturer to have a comprehensive quality management system, based on ISO 9001:2000 or recognized factory production control system combined with initial product type testing and regular audit testing. Once achieved, the Kitemark can serve as an enhanced marketing tool in a competitive market, by demonstrating an ongoing commitment to quality and safety.
CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Instructions. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials "CE" do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Instruction(s).
Need help or have a question?