According to the standardization body CENELEC, CE stands for Conformité Européenne. The CE marking is a requirement for the marketing of products within the European Union. The relevant product groups and technical areas include, for example, active implantable medical devices and the electromagnetic compatibility of equipment.
As part of our services, we offer you complete market approval in Europe. We carry out the necessary tests in our own laboratories and our experienced certification team including a notified body will pave your way to the European market with a CE marking.
In order to obtain CE marking, products with radio technologies must meet the requirements defined by the European Radio Equipment Directive 2014/53/EU (RED). This directive sets the legal framework for all products with radio technologies. The main requirements defined are health and safety, electromagnetic compatibility and the efficient use of radio frequencies. Manufacturers and suppliers of these products on the EU market must prove compliance with the RED by providing a type examination based on a technical documentation (TD) or a declaration of conformity (DoC) and the CE marking.
By definition, certification on the basis of the EN standards (EU) only represents access to the EU markets. Independent certification of products with radio technologies for other markets is therefore necessary. However, the testing effort is manageable, as a large number of the provisions for market access are based on the requirements for CE marking. In combination with FCC certification, a large number of requirements for international market approval are already covered.
Within the framework of an EU certification according to RED, we recommend cooperation with a Notified Body. As an independent organization notified by the European Commission, a Notified Body carries out the necessary conformity assessments and supports manufacturers, especially if no harmonized standards are applicable. A Notified Body carries out the conformity procedure on behalf of the applicant and can verify the assessment and the corresponding type examination (TCF).
When there is a deviation from harmonized standards or where these do not exist, a notified body can provide specific tests and help to define the corresponding test plans. In the case of non-harmonized (country-specific) frequency bands, it can provide support so that manufacturers can place their products on the market.
A notified body can deal with necessary approvals for the states of the European Economic Area (EEA) according to the RED and finally assess the type examination of a manufacturer and issue a type examination certificate.
As a notified body for various EU directives, we can support you in the CE marking process and help you gain access to the European market. Although a self-declaration procedure is permitted, some products require independent testing or certification by the notified body.
If you are not familiar with the procedure or if there are deviations from harmonized standards or if these do not exist, it is recommended to involve a notified body.
Our laboratory in Essen is accredited by the DAkkS according to DIN ISO 17025 to carry out a wide range of radio tests to receive a CE marking.
Detailed information on the scope of our accreditation for our laboratories in Germany can be found in our accreditation overview.
For a market launch in Europe, the declaration of conformity according to the RED and the resulting application of the CE mark is essential. In addition, there are various countries that have adopted the basic principles of RED as requirements for the approval of products with radio technologies in whole or in part. The approval for the European area thus serves as an ideal starting point for potential further international market approvals.
Since 13 June 2016, Directive 2014/53/EU (RED – Radio Equipment Directive) has replaced the previous Directive (1999/5/EC). From 13 June 2017, the RED is used for CE marking of products with radio technologies.
The essential requirements are defined as follows:
Combined Equipment is the physical connection between a radio system and a device which – considered separately – falls within the scope of another directive (e.g. Machinery Directive, EMC Directive, Medical Devices Directive).This could be a washing machine with Bluetooth module or an industrial printing system with Zigbee module. Before the introduction of RED, combined equipment was often considered separately with regard to the individual components, but now the focus of RED is on the end product. In addition to the obligatory measurements regarding the radio spectrum, RED may also include other measurements that have not yet been considered for the entire device.
Generally, the measurements are the basis for issuing the declaration of conformity, as they cover the essential requirements of Article 3 of the RED. Of course these measurements can also be carried out by the manufacturer. For reasons of quality assurance (Third-Party-Opinion) we recommend, however, the involvement of an independent test house for the final conformity measurements.
Usually not, since modules are in most cases not usually tested in the (host) environment in which they are installed at the terminal device level. Tests at the terminal device level are usually unavoidable.
Usually parts of the radio tests (especially conducted test cases) can be transferred to the end device.
If the end device and USB plug-in solution are marketed separately as independent devices, they shalleach meet the requirements of the applicable directive(s). If these individual components are brought together by the end user, he is usually responsible for the resulting system. If the devices are placed on the market together (as a bundle), or the USB plug-in solution is already integrated, then the person placing the devices on the market is responsible and shallalso examine the system for its conformity.
“RED-EMC” differs from “EMC-EMC” only slightly in principle -the tests to be performed are usually the same, and the degrees of immunity may change (e.g. EMS Field Measurement : 10V/m instead of 3V/m for industrial applications). For so-called “Combined Equipment”, standards of both directives can be applied, depending on the device.
Devices that are already on the market and, in addition, no longer meet current requirements can continue to be operated after e.g. maintenance/repair-related replacement of components without having to carry out a new conformity assessment. If the replacement of components does not require special expertise and is ideally described in detail in the operating instructions (e.g. replacement of an ink cartridge in a printer), the customer can also take over the replacement.
In the case of (stationary) systems, it is usually possible to dispense with evaluating the entire system from an RED point of view -the radio technologies used should, of course, comply with RED requirements. Influences of the radio technologies should, however, be included in a final conformity assessment of the system.
Yes – corresponding requirements can be found in Appendix C of standard IEC 62368-1:2018 (Edition 3.0). (Note: This version is currently not yet harmonized -neither under the RED, nor under the LVD.)