What is CE marking?

CE marking is a certification mark that must be legally affixed to products that must be in compliance with the essential requirements out of the European New Approach Directives. 'CE' stands for 'Conformité Européenne'. With the mark, the manufacturer, his authorized representative or the importer ( also for products imported from outside the European Union) indicate that the product meets the legal requirements described in the applicable directive (s). All products bearing the CE marking have free access to the entire market within the European Economic Area (EEA). Products that are not in compliance with the essential requirements out of the European Directives and further have no CE marking, can not be legally traded within the EEA.

What happens if my product is brought onto the market without CE marking?

If a product is unlawfully affixed with the CE marking the government will take economic measures as well criminal measures. Products can for example be withdrawn from the market and penalties can be imposed. There can under the law on economic crime demand made by the Prosecutor for manufacturers, importers or its authorized representative if proven that illeagule measures where taken.

Can the product be tested on site?

Often there are plants too large for easy transport. Therefore, products are tested on site where all aspects of the installation is inspected. An expert indicates clearly in a report what aspects are in complience in the product, and what aspects should be modified.

I am in a development phase with my product. How can I now take into account the CE marking?

Consultants Europe bv can offer support during the production process by indicating what requirements your product must comply with and by which standards this could be achieved. Likewise, the technical lawyers of Consultants Europe bv identify which (test) standards are used to measure the compliance of your product.

When I deliver components that will be built into an installation / or built into a unit, must it also be CE marked?

Yes, under the new Machinery Directive 2006/42/EC not completed machines (a combination of machinery but which can not in itself a specific achieve a specific application) fall also within the scope of the Directive.
This means that not complete machinery should be similarly certified. They must, just as complete machines, have a Technical File. These documents must give an insight to the design, manufacturing, risk assessment and operation of the not completed machines, this is necessary for the assessment of conformity with the relevant essential health and safety requirements.
They must also be accompanied by an installation manual and a installation declaration.

When all components of a product are certified, does the entire installation / unit as a whole yet to be certified?

Yes, the complete product in its entirety should be certified, even if all the components are marked with a CE marking.

What documents are required for CE-marking?

The New Approach Directives require that the manufacturer compiles technical documentation (Technical File) with information to demonstrate compliance with the applicable requirements. The contents of the TF varies per directive. In general, the design, manufacture and operation of the product (user manual) are described.
What details must be included in the TF depends on the nature of the product and what, from a technical perspective, is considered necessary to demonstrate that the product meets the essential requirements of the relevant Directive.
The manufacturer or his authorized representative established in the commumity is also required for EC Declaration of Conformity program. The EC Declaration of Conformity is a declaration by the responsible party represents and warrants that the product meets the essential requirements of applicable directives.

How long is an EC Declaration of Conformity valid?

The EC Declaration of Conformity is valid for an indefinite time after the essential safety requirements of the product is determined and remains valid for products as long as no major changes are made, ie products that have been repaired without the original operation, the original intended use or the original type is changed. Products to which significant changes have been made with relation to the original operation, the original purpose or type or intended use of the product, eg by using other components or new suppliers, can be considered as a new products. When such changes occur, a re-evaluation certification process must take place, possibly on the basis of the previous certification, and a proposal for a new EC Declaration of Conformity, in accordance with new guidelines and / or standards should be developed. The EC Declaration of Conformity must be at least ten years after the last date of manufacture of the product be kept, unless the directive expressly indicates another term.

What costs can be expected for the CE-marking process?

The cost of the CE marking process depends on the product that should be certified. Taken into account must be the various European directives and standards that apply to the product. If a several directives apply to a product, this will influence the cost. In addition, different test methods which are applicable will influence the various costs involved.
On the basis of (technical) product information, the technical legal experts of Consultants of Europe can indicate a price in a short time frame which can be followed by a official quotation.

How long does the CE marking process take?

The duration of the CE marking process depends on various factors. If first depends on the type of product and the fact to what extent the product meets the essential requirements in complience with the applicable directives. In some cases, the essential requirements can only be determined on site at the responsible party, this has a influence on the time frame and the period required for the certification.
The total duration of the CE marking process is also dependent on the party responsible for the modifications to the product to bring the product into conformity with the essential requirements of the applicable directive.

What is the procedure for CE-marking?

New Approach Directives broadly describe the essential requirements that products must meet. The manufacturer may indicate themselves as to how they will comply to the essential standards and directives. Often European (harmonized) standards (EN standards) are used to in the process . These standards give precisely the technical requirements that a product must meet. The application of harmonized standards, leads to presumption of conformity with the essential requirements of the applicable Directive (s). The CE marking symbolizes conformity to all requirements for the product according to the essential requirements out of the New Approach directives. The application of the mark rests with the responsible party. In addition to affixing the CE marking, the responsible party must comply with the following administrative requirements:

• EC Declaration of Conformity

The EC Declaration of Conformity is a document which the manufacturer(or his agent) or importer declares that the product conforms with the essential requirements of the relevant New Approach Directive (s). The declaration contains the following main elements:

1. Company name and complete address of the manufacturer and, where appropriate, his agent
2. Product identification (name, function, model, type, serial number and trade name and any relevant additional information)
3. The directives concerned and where appropriate harmonized standards or other technical standards and specifications
4. When appropriate the name and address of the person who is responsible to compile the technical file in the Community,
5. When appropriate name, address and identification number of the notified body
6. Identity and signature of the person authorized to act on behalf of the manufacturer or his representative to compile the declaration
7. The date on which the declaration is issued

• Technical File

The Technical File (TF) contains relevant information that must indicate that the essential requirements out of the applicable directive (s) have been met. The TF must be available for the competent authorities of the Member States for at least 10 tears after the date of construction of the machine or, in the series production, the last unit produced. For the manufacturer, his authorized representative or the importer, the TF also is used as technical evidence, that can offer possibilities of defense during a liability claim. The contents of the TF is must be in compliance and in accordance with the directives established for the products. In general a TF includes the following:

1. a general description of the product;
2. a risk assessment to identify health and safety requirements on the applicable product;
3. design and fabrication drawings;
4. detailed technical information on key aspects of the product;
5. a list of standards and essential requirements that are met;
6. reporting of calculations and tests;
7. certificates and test reports;
8. User Manual;

• Users manual

The New Approach Directives have a direct relationship with the safety of the user. The information that is given to the user plays an essential role in accident prevention and reducing the risks regarding safety. The preparation and provision of the safety instructions governing the use is fundamental legal safety requirements. The manual should contain all information necessary for the proper and safe use of a product.

Who can apply the CE-marking for me?

This is different for each product. For a large number of products with a low safety risk, the manufacturer can determine whether it meets the essential requirements out of the related Directives as long as the procedures are correctly followed. Products with a higher risk should be tested and verified by an external examination institution.

CE Approval vs. CE Mark for EU Directives

Clients often inquire about how CE Solutions can assist with CE approval. The word CE approval is not correct, as the CE mark is not an "approval" to market your product. Rather, it is a symbol affixed to your product labeling to indicate that it does in fact meet the requirements of the applicable European Directive(s).

Which countries belong to the European Economic Area (EEA)?

The following countries are part of the European Economic Area (EEA):
•The Netherlands
•Bulgaria
•Romania
•Belgium
•Luxembourg
•France
•Germany
•Italy
•United Kingdom
•Ireland
•Denmark
•Greece
•Spain
•Portugal
•Austria
•Finland
•Sweden
•Cyprus
•Estonia
•Hungary
•Latvia
•Lithuania
•Malta
•Poland
•Slovenia
•Slovakia
•Czech Republic

Must my product be CE approved?

Products covered by one or more New Approach Directive (s) must be provided with a CE marking. The New Approach Directives for the following product are established:

• Cableway installations designed to carry persons
• Construction products
• Electromagnetic compatibility
• Equipment and protective systems in potentially explosive atmospheres
• Explosives for civil uses
• Lifts
• Low voltage equipment
• Machinery safety
• Measuring instruments
• Medical devices: Active implantable
• Medical devices: General
• Medical devices: In vitro diagnostic
• New hot-water boilers fired with liquid or gaseous fluids (efficiency •requirements)
• Non-automatic weighing instruments
• Packaging and packaging waste
• Personal protective equipment
• Pressure equipment
• Radio and telecommunications terminal equipment
• Recreational craft
• Simple pressure vessels
• Toys safety