by Jack Black and Bill Stumpf
D.L.S. Electronic Systems, Inc. Wheeling, IL
The EU enacted formal legislation that withdrew the Radio and Telecommunications Terminal Equipment (RTTE) Directive 1995/5/EC and replaced it with the Radio Equipment Directive, 2014/53/EU, or RED. This new directive went into law effective June 13, 2017, after a one-year transition. This new directive incorporates several changes related to the scope, standards, and inclusion of safety and performance requirements. The EU will no longer accept a Declaration of Conformity that referenced the RTTE Directive. All products placed on the market or into use on the EU market must show the RED as the applicable referenced Directive for CE Marking and entrance into the EU marketplace.
Amateur radio products and radio kits, airborne electronics, marine electronics covered under the Marine Equipment Directive 96/98/EC, airborne type products found in Article 3 of Regulation (EC) No 216/2008 of the European Parliament and of the Council (2), and custom built experimental equipment are not included in this directive and are referenced in Annex 1.
The RED identifies wireless products that fall under the definition of equipment that intentionally emits or receives radio waves for the purpose of radio communication or radio determination, which makes use of the radio spectrum. This includes any transceiver, transmitter, receiver or product which contains a radio communication or radio determination function. Terminal equipment that does not incorporate any wireless feature, transmitter, or receiver, which was under the scope of the old RTTE directive, is not under the RED, and falls under the EMC directive, along with the Low Voltage Directives.
An electrical/electronic product which contains a radio function becomes a radio product in its entirety and therefore must comply with the RED. Consequently, if a manufacturer incorporates radio equipment into a non-radio product, then the product must be evaluated to determine if the incorporated radio equipment is compliant with the RED as installed in the finished product while the finished product is in operation. The rational for this is that the radio may affect the radiated, conducted or immunity characteristics of the host product, and conversely the host product may influence the functionality, radiated, conducted or immunity characteristics of the radio product.
Additionally, the RED now incorporates formal requirements for conditions found in the Low Voltage & Electromagnetic Compatibility Directives. It also identifies the need to test products for safety that were at one time outside the scope of the Low Voltage Directive, such as battery-operated devices. Most electric devices with wireless capabilities enabled will need to meet these safety provisions. Manufacturers are required to establish a risk assessment to determine operational and performance characteristics that are to be monitored and confirmed and to show risk elevations.
The list of applicable standards are published in the EU official journal, and are easily located at http://ec.europa.eu/growth/sectors/electrical-engineering/red-directive_en
The standards are published by ETSI and CENELEC, and can be located at http://www.etsi.org/technologies-clusters/technologies/regulation-legislation/red. Many of these standard incorporate operational and performance characteristics as part of the testing process.
After having incorporated a radio product, a manufacturer may elect to reuse the results of a previous EMC Directive or Low Voltage Directive assessment already carried out on their product. If so, the published guide ETSI EG 203 367 provides direction on the reuse of previous assessments based upon Harmonized Standards relevant to radio equipment under either the EMC Directive or the LVD, for example. Additionally, the safety portions of the RED include those for RF exposure, and those areas will need to be addressed as well.
This analysis should include compliance of the combined product including evaluation of the conformity assessment already carried out on the radio product to determine if any additional testing is necessary. This transitional assessment can determine if there is a need to repeat the entire conformity assessment already carried out by the manufacturer of the radio equipment or not. It is very important to make sure that current standard revisions are used when performing this assessment.
Involvement of a Notified Body may be needed where non-harmonized standards, non-published standards, Harmonized standards are used in part, or standards prior to effective date are used to show compliance with Article 3.2 of the Directive, and a EU-type examination certificate shall be issued that will allow for CE Marking of the product. It is up to the manufacturer to provide the notified body the information needed to determine if the essential requirements are met, and confirm compliance with the EU-type examination certificate.
The manufacturer is wholly responsible for the conformity of the product to all applicable EU requirements. This responsibility applies whether the product was designed and manufactured by the manufacturer, or is merely being placed on the market under the manufacturer’s name or trademark, and the manufacturer’s technical file should include any reports, conclusions, the risk assessment analysis and any technical documents relevant for compliance with the Essential Requirements. These technical documents should include design, manufacture and operation of the radio equipment (reference Annex V of the RED). This technical file must be completed at the time of placing the product on the market, as it may be requested for examination by EU market surveillance authorities, including any transitional or gap analysis. A detailed list is found in Annex V of the RED.
The manufacturer must prepare, provide, and have available a Declaration of Conformity (DoC). The DoC must be made available to the authorities of each Member State and must be translated into the language or languages required by the Member State in which the product will be marketed. The manufacturer may wait to translate the DoC into the different languages until requested by the authorities of the particular Member State. If so, a simplified DoC in each language will usually suffice. Additional information can be found in Annex VI of the RED.
Standards not listed under the RED may also apply and therefore should be listed on the DoC. For example, a household appliance with a radio function becomes subject to compliance under the RED, but compliance with EN 55014-1 and EN 55014-2 must still be considered as part of the compliance assessment of the appliance product. Similarly, additional EU directives may apply to a product integrating a radio. An example would be a machine subject to the Machinery Directive. In this case, RED standards and Machinery Directive standards, such as 60204-1 apply to the final product, and the Machinery Directive and the associated standard used would also be listed on the DoC.
The RTTE Directive is now withdrawn and the RED directive is applicable. Any product incorporating a radio automatically becomes a radio product subject to the requirements of the RED. Therefore, the DoC should reference the RED and the Harmonized Standards used to assess compliance with the Essential Requirements of the RED. The DOC should not reference the EMC Directive or the LVD, since they no longer apply to combined equipment, but should reference all the standards that were used to provide the presumption of conformity to the essential requirements.
April 2019