The key requirements concerning the safety, health and environmental considerations of electrical equipment have been harmonised on the European Union level, and they are defined in EU decrees such as directives and regulations. Many of the directives are so-called 'New Approach' Directives, where the directive only contains the essential safety, health, environmental and consumer protection requirements for electrical equipment, and the conformity assessment procedures. The technical details are specified in European harmonised standards. A harmonised standard refers to a standard confirmed by a European standardisation body at the request of the European Commission, with its reference information published in the Official Journal of the European Union.
How can I ensure and attest the conformity of electrical equipment?
If the design, manufacture, inspection, and testing of electrical equipment are carried out in compliance with harmonised standards and the equipment fully meets the requirements of these standards, the equipment is presumed to be in conformity with the applicable essential requirements (presumption of conformity). Such equipment can move freely on the EU market. The use of harmonised standards is, however, voluntary. The manufacturer may, alternatively, choose some other way of attesting conformity with the essential requirements of the directives. In practice, however, this approach is more difficult than following of established standards.
The Directives specify whether a Notified Body is required to be involved in the conformity assessment of the electrical equipment. A Notified Body is approved by a national authority to carry out conformity assessment tasks. They are notified to the European Commission and listed in the NANDO database. Market surveillance authorities do not inspect equipment before they have been placed on the market.
Once the manufacturer of the electrical equipment has drawn up the required technical documentation and demonstrated the equipment’s compliance with the applicable requirements in accordance with the conformity assessment procedure, the manufacturer shall draw up and sign an EU Declaration of Conformity. To attest and prove conformity, the manufacturer must affix the CE marking to every piece of equipment placed on the market.
In the serial production of electrical equipment, procedures must be in place to ensure that all equipment meets the essential requirements of the directives. Changes to the equipment's design or features, along with changes to harmonised standards or technical specifications on the basis of which the conformity of the equipment is declared, must be taken into consideration in the conformity assessment of the equipment.
When this is deemed appropriate with regard to the risks presented by the electrical equipment, the manufacturer shall, in order to safeguard the health and safety of consumers and the environment, carry out sample testing of marketed products; investigate and, if necessary, keep a register of complaints, non-conforming products, and product recalls; and keep distributors informed of any such monitoring.
Manufacturer who suspects that electrical equipment he has placed on the market is not in conformity with the applicable requirements shall immediately take the corrective measures necessary for bringing that equipment into conformity or to withdraw or recall it. Furthermore, where the equipment's characteristics present a risk to safety, health, or the environment, the manufacturer shall inform the market surveillance authority of the non-compliance and of any corrective measures taken.
The manufacturer shall retain the EU Declaration of Conformity, the technical documentation, and the identifying information of economic operators to which it has supplied the equipment for 10 years after the last electrical equipment has been placed on the market. Upon request, the manufacturer must present the above-mentioned information and documents related to the equipment to the market surveillance authority and co-operate with the surveillance authority.
Markings, information and instructions
Before placing electrical equipment on the market, one must ensure that the equipment bears all markings, instructions and information required in the directives, to ensure the safe and purposeful deployment, use, maintenance, and decommissioning of the equipment. Several standards applying to the equipment determine the compulsory information and markings that must be affixed to the equipment, also presenting detailed requirements concerning the information, instructions and warnings that the instructions must contain.
In addition to the CE marking, each piece of electrical equipment must have a type, batch, or serial number that allows its identification. The manufacturer must also state his name, registered trade name or trademark, and address on the equipment or, if this is not possible, on the packaging of the equipment or in the included documentation.
Read more in the Guide Manufacturing, Importing and Sales of Electrical Equipment.