Electrical and electronic products, and telecom equipment require the CE mark before they can be sold in the European market. The CE mark certifies that the product has been evaluated and meets the EU requirements for safety, health and environmental safeguard. The CE mark is valid for products manufactured both inside and outside the European Community (including Iceland, Liechtenstein and Norway), and is necessary for their marketing in the community.
For CE marking, products must be verified by adopting European Union specifications from ’.
In order to affix the CE mark, it is necessary to prepare a technical dossier demonstrating that the product complies with the EU requirements. The responsibility to declare compliance with all requirements falls exclusively on the manufacturer. Once the CE mark is obtained, the manufacturer may be required to provide to distributors and/or importers all supporting documentation.
How to obtain the CE mark
For the manufacturers the procedure is divided into several phases:
1. Identifying the EU requirements for the product
The EU requirements set out in the directives cover various types of products or sectors, for example:
- electrical equipment
- medical devices
- radios (including cellular telephony, Wi-Fi networks, remote controls and many other products)
These directives lay down the essential requirements which products must meet.
2. Checking whether the product meets specific requirements
It is up to the manufacturer to verify that the product meets all the requirements of European legislation. If for the product there are harmonized European standards and these are applied in a comprehensive manner, the product will be considered to be in conformity with the requirements laid down by the relevant directives.
The application of harmonized standards is the easiest and least expensive route to assess the conformity of products. It is possible to opt also for other technical and procedural solutions to meet the essential requirements of the applicable directives. These solutions typically require more in-depth technical assessments and often the involvement of a notified body.
To run technical tests the manufacturer may apply to a trusted external laboratory.
3. Preparing a technical file
The technical file must contain all the documents certifying conformity to technical requirements.
4. Checking whether the technical dossier must be submitted to a Notified Body
In the case of some products, it is required the intervention of appropriate conformity assessment bodies (“Notified Bodies”) that verify if the product meets the specific technical requirements. For most products this verification is not required if the relevant harmonised standards have been applied.
5. Affixing the CE mark and drawing up a declaration of conformity
At this point the CE marking can be affixed to the product. The mark must be visible, legible and indelible. If a notified body has intervened, It must also affix the notified body's identification number to the product. Finally, it is necessary to draw up and sign a Declaration of Conformity which certifies that the product conforms to all legal requirements.
If it is up to the manufacturer to ensure compliance of their products and affix the CE mark, importers shall ensure that the products they place on the market comply with the applicable requirements and that do not present a risk for Europe's consumers. The importer has to verify that the non-EU manufacturer has taken all the necessary steps and that the documentation is available upon request.
If importers shall undertake to ensure the compliance of the product in your name, they will need to have available all the documentation of the product itself, follow all the verification steps described above for the CE marking, performing checks on manufactured batches to ensure that compliance is maintained.
Distributors must have a basic understanding of legal requirements (that is, know which products must bear the CE mark and know the accompanying documentation) and should also be able to identify products that clearly do not meet. They must be able to demonstrate to national authorities that they have acted with due diligence and that they have received confirmation from the manufacturer or importer that have been taken the necessary measures. In addition, the distributor must be able to assist the national authorities in obtaining the necessary documentation.
What can Sicom do ?
SICOM performs all technical evidence and prepare the documentation for CE marking of different types of electrical products, electronic and for telecommunications. These include for example:
- transmitter or receiving radio products (radio controls, Wi-Fi products, ZigBee products, short devices SRD and other)
- products used in railways and in the marine sector
- Automation and control systems
- components for home automation
- mobile phones
- satellite Locators
The main directives are:
- Directive 2014/53/EU of the European Parliament and of the Council of the 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC
- Directive 2014/30/EU of the European Parliament and of the Council of the 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
- Directive 2014/35/EU of the European Parliament and of the Council of the 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
- Council recommendation 1999/519/EC of the 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields 0 Hz to 300 GHz
- Directive 2002/96/EC of the European Parliament and of the Council of the 27 January 2003 on waste electrical and electronic equipment (WEEE)
- Directive 2001/95/EC of the European Parliament and of the Council of the 3 December 2001 on the general product safety
- Directive 2008/57/EC of the European Parliament and of the Council of the 17 June 2008 on the interoperability of the rail system within the community
- Directive 2014/90/EU (ex 96/98/EC) of the European Parliament and of the Council of 23 July 2014 on marine equipment