CE Marking

The purpose of the CE Marking is to facilitate the free movement of goods within the European Union. The basis for this was a 'New Approach to Technical Harmonisation and Standards,' as seen in the EU's 'New Approach' Directives which set out 'essential requirements', written in general terms, which must be met before products may be supplied in the United Kingdom or anywhere else in the Community. European standards fill in the detail and are the main way for businesses to meet the 'essential requirements'. The Directives also say how manufacturers are to show that products meet the 'essential requirements.' Products meeting the requirements are to carry CE Marking, which should mean that they can be supplied anywhere in the EU.*

The "CE" marking is now mandatory for a wide range of products sold in the 15 countries that make up the European Union (EU). North American exporters could lose access to the EU market if they do not meet these requirements.

The CE Marking identifies a product as complying with the mandatory health and safety requirements spelled out in EU laws, known as "directives," which apply in all EU-member states. Each directive has a distinct deadline date. After the deadline, products covered by the directive no longer can be sold on the EU market without the CE marking. The laws are being enforced. Shipments of U.S. products not carrying the CE marking have been held at EU-member state borders. Moreover, companies that fail to CE marking products not only risk loss of sales but also face criminal prosecution.

A manufacturer must review all applicable directives, test products as specified in the directives, then must affix the CE marking to the product. There are about 30 directives, either adopted or under consideration which require the CE marking. For example, the Medical Devices Directive will be mandatory June 15, 1998 for all medical manufacturers exporting to the EU. This directive will affect more than 45% of U.S. medical exports consisting of over $3.5 billion annually.

Can I add other safety marks to the product if I have the CE Marking?

Other marks may be applied to the product to indicate safety standards have been complied as long as these marks do not obscure or become confused with the CE marking. Although the amending directive 93/68/EEC will remove the need to have safety marks from certification bodies as a way of showing legal compliance, it does not preclude the continued use of these marks. Often it is a customer or contractual requirement that such marks are on the product and these cases where it is felt that a commercial disadvantage may accrue from dropping the marks, they will be retained. They do not signify the same things as the CE marking.

These dates show when a particular Directive is effective and mandatory. When a Directive is effective(in force), the manufacturer has the choice of complying with the Directive or with the National requirements of the country to which they are selling. After a Directive becomes mandatory however, the manufacturer must comply with the requirements of the Directive as applicable to their product(s).

New Approach Directive	Effective Date	Final Deadline
Toys		January 1, 1990
Simple Pressure Vessels		January 1, 1992
Telecom. Terminal Equip.		November 6, 1992
Machinery		December 31, 1994
Active Implantable Medical Devices		December 31, 1994
Satellite Earth Station Equipment		May 1, 1995
Electromagnetic (EMC)		December 31, 1995
Gas Appliances		December 31, 1995
Low Voltage	January 1, 1995	January 1, 1997
CE Marking Directive	July 1, 1994	January 1, 1997
Elevators	January 1, 1995	December 31, 1997
Recreational Craft	June 16, 1996	June 16, 1998
Medical Devices (MDD)	January 1, 1995	June 15, 1998
Explosive Atmospheres	March 1, 1996	June 30, 2003
Non-Auto. Weighing Instruments	January 1, 1993	January 1, 2003

A few facts on CE-marking

What
The CE-mark is a mark that should be affixed to certain products in order to make it legal to sell them or to put them into service in EEA. It is primary a mark that tells the authorities that the product is manufactured to conform to certain requirements. The number of products that has to be marked is increasing constantly.

Why
The reason for the CE-marking is to achieve a technical harmonisation which gives the product free movement on the market. This free movement should not be restricted by different technical standards or safety rules. A product with affixed CE-marking is presumed to fulfil all relevant requirements in these respects and must not be hindered from being placed on the market. On the other hand, a product without CE-marking, which should have had it, must not be placed on the market or put into service.

Area
The CE-mark is required within EEA. This is an area made up of Eu and Iceland, Norway and Liectenstein (Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden).

Laws
The laws concerning CE-marking are national. They are founded on directives from Eu but are laid down separately in the different countries. Most often they are copies of the directives but small differences can exist. The meaning of the text shall be the same in all countries if nothing else is explicitly said in the directives.

Enforcement
The countries decide for themselves which authorities shall oversee the implementation of the rules. This is different in different countries, different laws are enforced by different authorities. The notified bodies knows what is appropriate in their country.
NB. It need not to be the Customs that enforces the law. In some cases it is unlawful to use products that is not CE-marked, i.e. the user is supposed to control that the product is duly CE-marked.

Marketing of products
By following all appropriate laws for a product in a country where all product-directives has been adopted, the manufacturer can expect free movement in all of EEA.
NB. New directives might come, they must be followed in order to keep the CE-mark.

Different directives
All directives for a product must be followed to affix a CE-mark legally. An electric machinery will normally have to comply with the directives for Machinery (89/392/EEC), EMC (89/336/EEC) and LVD (73/23/EEC) at the same time.

Notified bodies
Certain procedures requires co-operation with a notified body. They are private or public organisations that are approved by the Member States to carry out certification and other procedures. Most countries has several notified bodies, while some has none. The notified bodies are not limited to work within their country.

Harmonised standards
Most product directives are legal documents with loosely defined 'essential requirements' that are supplemented by 'harmonised standards'. These standards are harmonised to be used in all EEA countries and shall be used at design and construction of products. A product designed and constructed according to such standards is presumed to fulfil the requirements for CE-marking.