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.

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.

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.

ESSENTIAL REQUIREMENTS

The essential property of the EU legislation is to ensure high level of health and safety limits of products bearing CE marking. The essential requirements apply to the hazard inherent to a product. That is why, if not laid out in the harmonised standards, manufacturers must perform risk analysis and include the results in their technical files.

While essential requirements indicate the results to be achieved and the hazards to be eliminated, they do not give a clue on technical solutions or how to eliminate these hazards. Manufacturers can reach real solutions and application details using the related harmonized standards or specifications.

WHAT SHOULD A TECHNICAL FILE (TECHNICAL DOCUMENTATION) INCLUDE?

EU harmonization legislation imposes on the manufacturers the obligation of preparing a technical file containing information that proves the conformity of their products to the essential requirements and to keep this file for 10 years. The technical file which is under the manufacturer’s or the authorised representative’s responsibility can be a part of the quality system documentation in the quality-system based conformity assessment procedures.

Though the information to be included in the technical file is detailed in every regulation, it is generally the information and documents on the definition, purpose of usage, design, production and operation of the product. You can find detailed information on our website.