CE FAQ

CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993.
CE marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. The CE marking certifies that the products have met EU health, safety and environmental requirements that ensure consumer and workplace safety.
There are different steps for manufacturers:

1. Identify the EU requirements for your product. ...

2. Check whether your product meets the specific requirements. ...

3. Check whether your product must be tested by a Notified Body. ...

4. Test your product. ...

5. Compile the technical dossier. ...

6. Affix the CE marking and draft a declaration of conformity.
If the product falls under at least one of the CE marking directives, yes. There are penalties for not correctly CE marking a product, falsely CE marking a product or failing to CE mark a product for which it is required.
If you want to sell a product in one of these categories anywhere in the European Union, your product must meet the standards set by the rules. If your product meets the standards, it can bear a CE marking and be sold in the EU. CE stands for Conformité Européenne, which is French for "European Conformity."
CE Marking Is Required Only for the Following Types of Products:

• Toys

• Machinery

• Electrical equipment

• Electronic equipment

• Personal protective equipment

• Pressure equipment

• Medical devices

• Active implantable medical devices

• In vitro diagnostica

• Radio and Telecommunications terminal equipment

• Simple pressure vessels

• Gas appliances

• Lifts

• Recreational craft

• Equipment and protective systems for use in explosive atmospheres

• Non-automatic weighing instruments

• Cableways

• Construction products

• Explosives for civil use

• New hot water boilers

• Measuring Equipment
The Declaration of Conformity is a special document which the manufacturer signs to say that the product meets all of the requirements of the applicable directives. It must be issued by the manufacturer, or by the person placing the product on the EU market if the manufacturer is not based in Europe.
The manufacturer of a product is responsible for ensuring compliance with European Directives and for affixing the CE marking – irrespective of whether the manufacturer is located within or outside the European Union. To do this, manufacturers may appoint an authorized representative established in the European Union to act on their behalf.

The CE marking is generally a declaration by the manufacturer, importer, or the entity first placing the product on the market that the product conforms to the

appropriate directives. This is confirmed by the legally binding signature on the Declaration of Conformity.
CE marking indicates to EU regulators that your device meets all applicable requirements of the appropriate EU Directive, such as the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD), as they apply to your product.
FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III. Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls.
CE Marking is required for most in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In Vitro Diagnostics Directive (98/79/EC), and that the device may be legally commercialized and distributed in the EU.
Yes. The manufacturer uses the CE Marking to indicate that the device complies with the essential requirements established in the applicable Community Directive/s.

The symbol is affixed by the manufacturer or their authorised EU representative. In exceptional cases, when permitted by the directive, it can be affixed by the party responsible for putting the product on the market in the EU. It must be affixed at the end of the production phase and be of an appropriate size (no smaller than 5 mm) and, where possible, must be placed on the product or the data plate.

It must be visible, legible and indelible. No other symbols that could be confused with the CE Marking can be featured.
The manufacturer uses the CE Marking to indicate that a device complies with the essential requirements established in the applicable Community Directives. Therefore, if products are not compliant, they cannot be put on the market.

For control purposes, the Government sets annual inspection plans (Industry, Consumption, etc.) aimed at establishing fines, removing from the market or blocking the circulation of devices that endanger the safety or health of people, goods or the environment, both in Spain and all other EU Member States.
The technical file contains all the evidence required to support the declaration of conformity. Each directive specifies the content of the technical file. The technical file requirements for each directive are different, so a technical file which supports a declaration of conformity covering a range of applicable directives must include all of the required sections from all applicable directives. Technical files must be retained and made available for inspection when requested by an enforcement authority for a period defined in the directive. In the case of the machinery directive, the period is 10 years after the last product was manufactured.
Enforcement, or market surveillance, is undertaken by nominated public authorities (Market Surveillance Authorities) in each member state, and each state has separate ways of enforcing the legislation once it has been implemented into national law.

The following bodies, amongst others, are responsible for CE marking enforcement:

• Trading Standards Services

• the Health and Safety Executive

• the Medicines and Healthcare products Regulatory Agency

• the Vehicle Certification Agency

• the National Measurement Office
Countries where CE Marking is mandatory are as follows :-

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland
Following are some directives in which involvement of a notified body is must.

• Simple Pressure Vessels Directive

• Appliances Burning Gaseous Fuels Directive

• Most products covered by the Pressure Equipment Directive

• Most products covered by the Equipment and Protective Systems in Potentially Explosive Atmospheres Directive
Following are some directives in which involvement of a notified body is not required

• Safety of Machinery Directive

• Electromagnetic Compatibility (EMC) Directive

• Low Voltage Directive

• Class I products of the Medical Device Directive

• Most products covered by the Radio and Telecommunications Terminal Equipment (R&TTE) Directive