The CE marking symbolizes that a product it is affixed to is in conformity with all relevant essential requirements of the European technical regulations ("Directives"), and that the product compliance has been established using the appropriate conformity assessment procedure(s). The ‘essential requirements’ are requirements related to product safety, public health and consumer protection.

CE marking is obligatory for any product covered by one or more of the European technical regulations requiring the affixing of the CE marking. Without the CE marking, these products are not allowed to be placed or to be put into service in Europe. In this regard, the CE marking sometimes is called a ‘trade passport’, because like carrying a passport when entering a country, the CE Marking is required for market access.

The need of CE marking:

The European CE certification procedure has been mainly set up to:

1. Harmonize all varying national regulations for consumer and industrial products in European Member States, so that the Single Market is encouraged;
2. Bring about cost savings for producers;
3. Enhance the safety of products;
4. Supply public bodies with a uniform procedure that can be checked.

With the help of the conformity assessment procedures, the authorities can ascertain that the products that are placed on the market comply with the requirements as stated in the regulations of the directives. The CE marking is consequently largely for the benefit of the authorities. However, safe products are also necessary for the end user in the work or consumer environment.

What are the benefits of CE Marking?

The CE Marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 18 countries of the European Economic Area (EEA).

There is only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. Various conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.

The CE Marking is required only for the following types of products:

• Toys
• Machinery
• Electrical equipment
• Personal protective equipment
• Pressure equipment
• Medical devices
• Active implantable medical devices
• In vitro diagnostics
• Radio and Telecommunications terminal equipment
• Simple pressure vessels
• Gas appliances
• Lifts
• Recreational craft
• Equipment and protective systems for use in explosive atmospheres
• Non-automatic weighing instruments
• Cableways
• Construction products
• Explosives for civil use
• New hot water boilers

• Chemicals
• Pharmaceuticals
• Cosmetics
• Foodstuffs

Requirements for Affixing of the CE Marking

The CE Marking must be affixed to the product, to its data plate or, where this is not possible or not warranted due to the nature of the product, to its packaging, if any, and to the accompanying documents by the manufacturer, the authorized representative in the European Community or, in exceptional cases, by those responsible for placing the product on the market.

How IQMS can help?

IQMS ensures that the products of a company comply to the CE marking and CE certification regulations.
 Our expert CE marking services consist out of:

• Verifying product documentation
• Modifying and testing products to ensure compliance with CE marking regulations
• Compiling CE mark Technical construction files
• Applying CE marking
• Authorized Representation

Implementation Plan:
 
Seven Steps of CE-Marking

Step1: The first steps towards CE-marking your product is determinig your product's application and establishing which directives apply to it.

Step2: Applying standards
The process is getting your product to meet the essential requirements laid down in the directives.

Step3:
Make sure your product is safe and be able to prove it. So carry out a risk assessment or analysis and show how you meet the requirements laid down in the directives.

Step4: Technical document
Drawing up technical documentation or a technical file, intended to provide information on the design, manufacture and operation of your product.

Step5: User Manual
The fifth step is to apply the product with instructions for the end user, including legal obligations, instructions for use and clear documentations, stating the purpose of the product and the risks related to its use under normal circumstances.

Step6: Declaration of conformity
The sixth step is the declaration on conformity, one of the final steps in the CE marking procedure. The declaration of conformity must contain all relevant product information, including which EU directive(s) the product now complies with.

Step7: Affixing the CE mark