CE Marking - The New Approach Directives

CE mark

Continually improve your business with the CE mark

The CE marking (on French “Conformité Européenne” – European conformity) is a must mark on many products within the single market in the European Economic Area (EEA). The label certifies that the product meets essential requirements for consumer safety, health or environmental protection, as determined according to EU guidelines or regulations.

The CE marking is not a third-party certification mark, but directly by the manufacturer or manufacturer’s representative (for example, the importer) on products of the widest possible range, such as toys, building materials, simple pressure equipment, radio and telecommunications equipment, medical devices, personal protective equipment, non-automatic and weight measuring equipment, fitness equipment, elevators, protective equipment for work in explosive atmospheres, measuring instruments, medical equipment, nautical equipment, satellite equipment, gas appliances, high pressure equipment, electrical equipment, steam boilers, civil explosives, refrigeration equipment, etc.

Thanks to the CE marking, you can freely place your goods in any country of the European Union, where it will not be subject to any additional testing by national institutions.

Stage

1. Compliance

Find out what the CE mark really is and what makes it suitable for your business.

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2. Implementation

Find out the best way to implement CE mark and how our company can help you with this.

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1. Compliance

Conformity assessment procedures are set up in accordance with these directives. Conformity assessment includes the phase of product appropriation and/or production phase. For certain product groups, conformity assessment procedures are required, after which the CE marking is affixed to products as a confirmation of that compliance.

Compliance procedures for the CE marking are divided into eight basic modules that combine depending on the manufacturer’s choice and depending on the options that individual directives allow:

• Module A – internal production control;

• Module B – examination of the EC type of directive;

• Module C – compliance with the type of directive;

• Module D – quality assurance of production;

• Module E – product quality assurance;

• Module F – product verification;

• Module G – individual product verification;

• Module H – complete quality assurance.

2. Implementation

The procedure for placing the CE marking includes the following steps:

• Determining which directive (or directives) refers to a product;

• Determining the conformity assessment procedure;

• Determining the date on which the directive gets in effect;

• Establishing a list of harmonized standards for a given product;

• Check by the manufacturer whether the product complies with the essential requirements of the Directive;

• Determination by the manufacturer whether a conforming assessment is required by an independent third party;

• Preparation of technical documentation;

• Preparation of the statement of conformity and the necessary documentation that proves it;

• Checking whether the country on which the product is being marketed has some additional requirements;

• Setting the CE marking on the product and/or packaging and documentation.