Compliance for Europe
All electronic devices bound for the European market are required to be labelled with a CE mark. The CE mark requirements are different to the Australian RCM and are far more extensive in terms of compliance testingrequirements.
What is the CE Mark?
CE is an acronym for the French term ConformitéEuropéenne, which is translated into English as European Conformity. The CE mark is a symbol used to show European authorities that a product meets the essential safety requirements for operator and environment. The CE mark is not a quality mark or guarantee, but is a type ofpassport for your device.
What do we use the CE Mark for?
In order to supply products into the European Union it is mandatory that these products comply with and be labeled in accordance with the CE requirements. The application of the CE mark to a product declares that the product complies with the applicable European Directives. The CE Mark will also facilitate cross border access of your product within the European Union.
What are the requirements?
European regulatory requirements (laws) are called Directives and are developed and implemented by the European Commission. For electronic equipment requirements will include EMC and Electrical Safety. The European Directives that will generally apply to electronic/electrical products are the EMC Directive 2014/30/EU and the Low VoltageDirective 2014/35/EU.
Generally compliance with a series of European Harmonized standards or European Norms (EN s) is required to show compliance for each Directive. Compliance with the relevant standards provides confidence that the equipment conforms to the essential requirements. If the equipment meets the requirements in the relevant standards themanufacturer can affix a CE mark to the equipment and generate a Declaration of Conformity (DoC).
There is no requirement for suppliers of electronic/electrical products to obtain a certificate or licence from a governing body in order to obtain compliance. The manufacturer will selfdeclare compliance with the applicable European Directives by completing a Declaration of Conformity and affixing the CE mark.
Declaration of Conformity
The Declaration of Conformity (DoC) is a document stating compliance of a product with each applicable directive and the relevant standards used to show compliance. The declaration of conformity is a type of statement that the product is believed to meet the essential requirements.
A copy of the DoC needs to be included in the shipping documentation for each piece of equipment shipped to the EU and must include the following:
- A description of the equipment;
- Reference to the standards tested to;
- The applicable Directives complied with;
- Identification and signature of the manufacturer (or his EU authorised representative);
- A declaration that the apparatus conforms to the essential protection requirements;
- The manufacturer’s name and address.
A Technical File should be held by the manufacturer (or his EU authorised representative) and should include the Technical Test Report, the Declaration of Conformity and detailed Product Information. A Technical File should be held for each product series and all compliance records should be in English. This file may need to be presented to a regulatory authority if a complaint is made regarding compliance of your product.
Where can I find more information?
If you have further questions, require a report assessment or product testing, or simply need assistance with your RCM compliance records then please contact Compliance Engineering on 03 9763 3079.