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Ce Certificate

The CE Marking is mandatory European marking for certain products group in conformance with the CE Directives with essential health and safety requirements CE means Conformities European in other words, European Conformity.

The product cannot be placed for service in the market without complying with the provision of the directive in the member countries in European Union. These CE Marking can be regarded as the product trade passage for Europe and many other countries worldwide that also accept and follow to CE Mark requirements.

CE Marking is independent of the quality requirements of the product as it applies with mandatory European safety requirements.

What is CE Marking?

1-Notified Bodies

2-Where is CE-Marking Required?
3-What To Look For In A Notified Body

4-Does Your Product Require CE Marking?

5-Who's Going To Enforce The Requirement For CE Marking?

6-What's New About the New Approach?


The CE Marking is mandatory European marking for certain products group in conformance with the CE Directives with essential health and safety requirements CE means Conformities European in other words, European Conformity.

The product cannot be placed for service in the market without complying with the provision of the directive in the member countries in European Union. These CE Marking can be regarded as the product trade passage for Europe and many other countries worldwide that also accept and follow to CE Mark requirements.

CE Marking is independent of the quality requirements of the product as it applies with mandatory European safety requirements.

 

The European Union (EU) includes the following 25 Member States: Austria, Belgium,Denmark, Eastland, Finland, France, Germany, Greece, Hungary, 

Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, Poland, Portugal, Slovakia, Slovenia, 

Spain, Sweden, The Netherlands, Czech Republic, UK and Cyprus. These Member States differ in their constitutional and legal systems.

Where harmonization of legal requirements or administrative regulations is necessary, the European Commission -the executive body of the European Union- develops regulations, which after acceptance by the European Council, are called Council Directives or simply directives. Each directive describes the consensus that has been achieved and provides a deadline for the transposition of this consensus into the national laws of each MemberState.

In 1985 a European Council Resolution on a new approach to technical harmonization and standards proposed a radical change in regulating the technical aspects of industrial products. The new approach involves the development of legislation specifying only the essential requirements that are general and mandatory. The detailed technical specifications that may be used to demonstrate conformity with the essential requirements are elaborated in voluntary harmonized standards.

Since 01 January 1993, the completion of the internal market has allowed free movement of goods throughout the territory of the European Union. A condition for such freedom of movement is the application of technical harmonization directives -also referred to as new approach directives- covering a wide range of industrial products such as machinery, personal protective equipment, medical devices, telecommunication terminal equipment, toys, and in vitro diagnostic medical devices and so on.

The conformity assessment of a product or family of products may require the certification by a Notified Body as regulated in the respective directive. Lists of Notified Bodies, the tasks and responsibilities which have been assigned to them and their unique four digit identification number is published and updated in the Official Journal of the European Communities.

If certification is a requirement as part of the conformity assessment procedure, the manufacturer has the option to choose any of the Notified Bodies in any of the Member States of the European Union. 

If a product complies with the requirements of a new approach directive, the manufacturer marks it with the CE-mark. Products which require certification by a Notified Body carry the CE-mark in combination with the number of the Notified Body, for example:

 

1-Notified Bodies  

 

The European new approach directives require the involvement of third parties in the conformity assessment of certain products. Traditionally these third parties had been national authorities of the Member States. However, some Member States had gained good experience in delegating technical work to non-governmental entities. These non-governmental entities were unknown to some Member States and to the European Commission. As there were no uniform criteria for the designation of such entities, the development of European legislation was relatively difficult.

 

The new approach reoriented EU legislative policy on such matters as technical competence, objectivity and transparency as the foundations for the necessary degree of trust in the system, on the basis of documented technical criteria enshrined in the legislation itself and in the appropriate European standards (i. e. EN 45000 series). Member States are invited under all new approach directives to notify the Commission of those bodies which they consider competent to undertake the responsibilities of Notified Bodies. A clear distinction shall be made at the national level between the Notified Bodies who intervene in the pre-market conformity assessment procedures and the national public authorities (national, regional or local) responsible for the market surveillance imposed by the directives for products on the market. 

 

Notified Bodies are free to offer their conformity assessment services for which they are notified to any manufacturer established either inside the EU or in third countries. They may carry out these activities on the territory of other countries either with their own personnel or with subcontractors.

At the time of the first notification with respect to a new approach directive the EU Commission assigns a four digit identification number to the Notified Body. This number will not change when the same Notified Body is notified for other directives at a later stage.

 

Notified Bodies are under surveillance by their national notifying authorities which have the authority to withdraw or modify the notification as soon as the conditions of notification are no longer met.

 

Notified Bodies are and must remain third parties, independent of their clients and other interested parties.

 

With respect to the European Medical Devices Directives Notified Bodies are entitled to perform product as well as quality system management related conformity assessment procedures as outlined in the respective Articles and Annexes of these Directives. Notified Bodies may have a limited scope with respect to the device families and/or the Annexes for which they are notified.

 

2-Where is CE-Marking Required?  

CE-marking compliance is a legal requirement in the European Union member states and the European Economic Area countries. The countries are:


Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,  

Finland, France, Germany, Greece, Hungary, 

Iceland, Ireland, Italy, Latvia, Lichtenstein, 

Lithuania, Luxemburg, Malta,Norway, Poland, 

Portugal, Slovakia, Slovenia, Spain, 

Sweden, The Netherlands, Turkey, UK 

 

Other countries are likely to adopt the Directives in the future.

3-What To Look For In A Notified Body     

Once it is determined that you manufacture a product that is not subject to the self-certification route, the best way to proceed is to contact a notified body whose qualifications match up with your product, and whose credentials and affiliations match up with your and your target market. After that, there are number of variables to be considered.

  • - Price - Obtain quotes from at least a few notified bodies; pricing can vary dramatically.
  • - Service - Many notified bodies do not provide adequate service; usually due to peak load situations, lengthy European vacations and some simply disregard customer needs.
  • - Consulting - Some notified bodies will (and some will not) offer advice in addition to testing to accelerate the process and simplify the process for you (such as a desk audit of your technical documentation prior to actual submission).
  • - ISO 9000 and Product Certification - Very convenient and economical (when both are required) if a notified body can provide both services.
  • - Documentation - Find a notified body that will accept documents in English. Copyright 2007
  • - Mutual Recognition - Look for a notified body that will accept ISO 9000 registration from a U.S. registrar to avoid duplicate costs; also, find a notified body that will consider using qualified U.S. based subcontractors for audits to reduce travel related expenses.

If you can't find a Notified Body who will comply with the items listed above, keep looking, they do exist.

4-Does Your Product Require CE Marking?   

  • CE Marking is required if your customers are citizens of certain countries and if they purchase certain types of products from you.
    1. Are your current or future customers in the following countries?
    European Union (EU) member states - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden and United Kingdom.


European Free Trade Association (EFTA) members - Iceland, Liechtenstein and Norway.

Do you now, or will you in the future, ship to these customers the following types of products?

  • - Toys
  • - Construction Products
  • - Pressure Vessels
  • - Telecommunications
  • - Medical Devices
  • - Machinery
  • - Personal Protective Equipment
  • - Satellite Station Equipment
  • - Gas Appliances
  • - Pressure Equipment
  • - Appliances (other than gas)
  • - Non-automatic weighing instruments
  • - Recreational Craft
  • - Lift Machinery
  • - Equipment and Protective systems for explosive atmospheres
  • - Non-Automatic Weighing equipment
  • - Measuring Instruments
  • - In-Vitro Diagnostic Medical Devices
  • - Marine Equipment
  • - Electrical products

5-Who's Going To Enforce The Requirement For CE Marking?    

Each member state of the European Union is bound to adopt into their National Law, regulations and administrative provisions to ensure that products placed on the market are safe. Each country has its own way of handling enforcement.


Many have added staff specifically to conduct spot checks against implemented directives and respond to complaints. Countries have also set in place a combination of return-to-origin procedures, financial penalties, criminal prosecution, etc.

European Union legislation makes European importers liable for the products they import, including the machinery they provide to their employees for work under the PUWER Directive. U.S. exporters are finding that no matter how interested a prospective European customer may be in their product, they will not risk importing non-conforming products when accidents will generate legal action against them. 

6-What's New About the New Approach?   

The implementation of the New Approach policy resulted in the changes outlined below: 

Product Directive Content: directives will be limited to the "essential requirements" or performance levels to which the product must conform.

Previously, the directives included detailed technical specifications which took forever to prepare since it involved the wrong level of bureaucracy and expertise.

Harmonized Standards: the technical specifications required of products to comply with the directive will be established by European standards agencies (CEN, CENELEC, ETSI and EOTA).

Compliance Procedures: the directives are linked to a series of compliance modules based on 4 factors including the nature of risk involved. There is a concerted effort to provide a range of choices to the manufacturer.

CE Marking:  common rules established for the affixing of the CE Marking to products.

Benefits of the CE Marking

 

  • - Accommodate all verifying national regulation for consumer and individual product in European Member states as it single market.
  • - Bring about cost saving for the producer.
  • - Enhance safety of the product 

Supply public bodies with uniform procedure that can be checked

How Do You Acquire CE Marking?

There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.

  • -  Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
  • -  Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
  • -  Choose the conformity assessment procedure from the options called out by the directive for your product.

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Options for products with minimal risk include self certification where the manufacturer prepares a declaration of conformity and affixes the CE Marking to their own product.

Options for products with greater risks can require tests, audits or additional certificates from a notified body.

  • - Select the applicable product standards and test methods for your product and select an independent lab If the product testing is to be done externally.
  • Establish an authorized representative for regulatory affairs in the European Union for your product. Some directives require that a manufacturer designate in Europe a representative to produce technical documentation in a timely fashion when called upon to do so.
  • - The directives require for many products that a technical file be prepared by the manufacturer. The technical file holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
  • - Prepare a declaration of conformity that includes a list of the directives and standards that your product conforms to; product identification, the manufacturer's name, address and signature.

The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.

Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging and material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.