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CE marking

The Most Effective Way to CE marking

Kiwa Dare is a leading laboratory in the Benelux in the field of tests and measurements in accordance to the European directives for CE marking. At this point, more than 30 European directives exist. Kiwa Dare performs tests and measurements for five of those directives. Amongst other things, Kiwa Dare performs measurements and tests for the EMC-, Machine-, Radio-, and Low Voltage directives and the Medical Device Regulation. Moreover Kiwa Dare also performs measurements and tests as part of E-marking, the international automotive marking, conform R10 and R100 of the United Nations.

What is CE marking

The term CE marking sometimes leads to confusion. The term CE marking is used for the CE label and comprises of the characters C and E both lying on two circles. Furthermore, the term CE marking is often used as a word to indicate the conformity process of CE marking. This is not correct, since only the conformity assessment procedure can show compliance. The usage of the term CE marking for both activities causes confusion and unwarranted expectations. Especially when a directive indicates that adaptation of the CE marking is not required. The procedures of 'CE marking', however, must be followed. This way, the EMC-directive indicates/suggests that for fixed installations the application of the CE mark is not required and that there is also no requirement for a Declaration of Conformity to be issued, but it does imply that the installation does have to suffice with the essential requirements of the EMC-directive. The conformity assessment does have to be followed. However, it's not required to attach the label.

CE marking

Directive No. Mandatory Since
Machine Safety 2006/42/EC 29-06-2008
Medical Device Directive 93/42/EEC 14-06-1998
Restriction of Hazardous Substances in Electrical and Electronic Equipment
2011/65/EU
22-07-2019
Electromagnetic Compatibility 2014/30/EU
20-04-2016
Radio Equipment
2014/53/EU
20-04-2016
Low Voltage
2014/35/EU 20-04-2016

Why CE marking?

The European Union (EU) strives for free trade between member states. In order to achieve this objective, the European Commission has established the CE Scheme Directives over the years before "Europe 2001". Local governments have agreed among each other to convert these directives into national legislation. In this way trade barriers, in the form of a wide range of national product requirements are removed. The most important purpose of CE marking is thus to reinforce the free trade. Besides, CE marking is also imperative to a safe and interference-free world. The most important purpose of CE marking is thus to reinforce the free trade. Besides, CE marking is also imperative to a safe and interference-free world. 

European Authorized Representative

Whenever a manufacturer outside the European Community or an importer does not want to be the holder of the Declaration of Conformity (DoC) and the Technical Construction Dossier (TCD) they can assign a so called authorized representative. Some companies like European Authorised Representative (EAR) provide such a service. The New Legislative Framework puts more stringent requirements on importers. Due to this, the role of European Authorised Representatives will likely increase.

Kiwa Dare Services performs tests and measurements in accordance to the European Directives and is as such enabling customers to apply CE marking.

What is CE marking?

The CE mark is the official mark required by the European Community for all electrical and electronic equipment that is be sold, or put into service for the first time, anywhere in the Community. It proves that the product fulfils all essential safety and environmental requirements as they are laid down in the European Directives. The CE Marking directive (93/68/EEC) was adopted on 22 July 1993. Kiwa Dare Services performs full compliant measurements in accordance with the following directives: Relevant directives that do not fall under CE marking.

Conformité Européenne

Products that come under the 'New Approach' directives, and comply with their requirements, have to be marked with the CE mark (Conformité Européenne) by the manufacturer. Products that come under a directive, but are not CE marked, are no longer allowed to be sold or put into use. The CE mark itself can be placed on any product whether it is the end product or a subcomponent. The manufacturer is free to choose whether he certifies all subcomponents for maximum flexibility or the finished product to keep costs down. The CE mark is not intended as a guarantee of quality for the consumer, but shows that a product complies with the fundamental safety requirements of the applicable directive.

Directives

Before 1985 directives demanded specific and detailed requirements per product or category. Later on, the European Union took another approach, the so-called 'New Approach'. Directives in accordance with this move contain broad product categories that define fundamental requirements in the areas of safety, health, environment and protection of the consumer. These fundamental requirements are first roughly formulated and then more precisely worked out as harmonized standards. The requirements in the directive indicate with which standards a product has to comply. The standards indicate how to achieve this result.

European Economic Area

On January 1st 1994 the EU and the EFTA countries (later on also Liechtenstein), with the exception of Switzerland, signed an agreement for the creation of a European Economic Area (EEA). Based on this agreement, the EU directives will also be part of the national legislation of the EFTA countries and the CE Mark will be accepted in those countries. By putting the CE Mark on its products the manufacturer or importer declares that the product satisfies ALL applicable directives. For this purpose a "Declaration of Conformity" has to be drawn up and signed by an authorized person from the manufacturer or importer. The Declaration of Conformity contains a unique identifier for the equipment, an identifier of the manufacturer or importer, a list of directives the product complies with and a dated signature. CE marking is a self-certifying procedure thus the manufacturer or importer remains liable for the product at all times.

CE marking Directives

No. Directive Identification
1. Safety of toys 88/378/EEC
2. Simple Pressure Vessels 87/404/EEC, 90/488/EC
3. Construction Products 89/106/EEC
4. Electromagnetic Compatibility (EMC) 2004/108/EC (89/336EEC, 92/31/EC)
5. Safety of Machinery 2006/42/EC
6. Personal Protective Equipment (PPE) 89/686/EEC, 93/95/EEC
7. Non-Automatic Weighing Instruments 90/384/EEC
8. Active Medical Implant Devices (E) 90/385/EEC
9. Gas Appliances (E) 90/396/EEC
10. Telecommunications Terminal and Satellite Earth Station Equipment 98/13/EC
11. Medical Devices (E) 93/42/EEC
12. Equipment Explosive Atmospheres (ATEX) 94/9/EEC
13. Elevators for Personal Use (lifts) 95/16/EEC
14. Recreational Crafts (E) 94/25/EEC
15. Explosives for Civil Use 93/15/EEC
16. Low Voltage 2006/95/EC (73/23/EEC)
17. Cableway installations designed to carry persons 00/9/EC
18. In Vitro Diagnostics 98/79/EC
19. Non Automatic Weighing Instruments 90/384/EEC
20. R&TTE Directive 99/5/EC
21. Packaging and Packaging Waste 94/62/EC
22. Pressure Equipment 97/23/EC

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CE marking
CE marking