When the European Union’s (EU’s) Radio Equipment Directive (2014/53/EU, also referred to as the RED) came into force on June 13, 2016, there was a one year transition period during which manufacturers had the choice of declaring compliance with the EU’s Radio and Telecommunications Terminal (R&TTE) Directive (1999/5/EC) or the RED. However, beginning June 13, 2017, only the RED can be used for conformity as the R&TTE Directive will be repealed on June 12, 2017. Beginning June 13, 2017 all manufacturers must have their Declaration of Conformity (DoC) updated to reference the RED. The most logical (and common) way to show compliance is to test a product to Harmonized Standards, which offers a presumption of conformity with the Essential Requirements of the Directive for the product.
In this article, we will define what equipment is covered by the RED, followed by the procedures for conformity assessment to the Essential Requirements of the Directive. Finally, we will discuss the obligations placed on the manufacturer and what must be included in the DoC.
What Does the RED Cover?
The RED defines the scope of equipment covered as “equipment which intentionally emits or receives radio waves for the purpose of radio communication or radio-determination [and] makes systematic use of radio spectrum.” Effective June 13, 2017, any transceiver, transmitter, receiver or product which contains a radio communication or radio determination function must comply with the RED requirements. This includes equipment that was approved under the R&TTE Directive which will be withdrawn June 12, 2017. Products which previously did not include a radio or radio function and which were subject to EU’s Directive on Electromagnetic Compatibility (the EMC Directive) and the EU’s Low Voltage Directive (LVD) now become radio products by the addition of a radio functionality.
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.
Harmonized standards under the RED take into account the influence from radio to the EMC behavior and vice versa. Since they offer presumption of conformity with the Directive, the use of Harmonized Standards offers the best route to compliance.
In cases where a radio product is being integrated into a host product, the manufacturer of the final product should assess the risks associated with the equipment use.
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 assessment does not necessarily imply the need to repeat the entire conformity assessment already carried out by the manufacturer of the radio equipment.
After having incorporated a radio product, a manufacturer may elect to reuse the results of a previous EMC 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 RED.
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.
Complying with the RED
So exactly how does a manufacturer go about the task of complying with the Directive? The Essential Requirements of the RED include radio (spectrum matters), EMC (emissions and immunity), and product safety (electrical safety, RF exposure). In an effort to assist manufacturers and industry to comply with the new RED requirements, the European Telecommunications Standards Institute (ETSI) has released a guide (EG 203 367) for the application of articles 3.1b (EMC) and 3.2 (effective and efficient use of the radio spectrum) of the RED.
In theory, the transition for most manufacturers should be relatively simple. The manufacturer would simply test their product for the appropriate radio, EMC, and product safety standards listed in the RED and then self-declare compliance of their equipment with a DoC. However, for now at least, this process may not be so easy. That’s because at the time this article was written (February 2017), only a limited number of Harmonized Standards for the RED have been published in the Official Journal of the European Union. These Harmonized Standards would normally be used to provide presumption of conformity with the essential requirements of the RED. But the limited number of Harmonized Standards currently published and available for use leaves the manufacturer with two choices: 1) wait until applicable standards are published, or; 2) use a Notified Body.
Regarding option 1, the limited number of Harmonized Standards currently available is a temporary situation. In August 2015, the European Commission requested ETSI and CENELEC to produce Harmonized European Standards for the RED to be published in the Official Journal, which manufacturers could then use to demonstrate a presumption of conformity with RED requirements. ETSI and CENELEC are fervently working on writing these standards, and updated lists of Harmonized Standards under the RED are being published almost monthly in the Official Journal (for example, an updated list of 47 separate Harmonized Standards was published in January, 2017). Readers can view the progress of ETSI’s program to develop additional Harmonized Standards under the RED at http://www.etsi.org/technologies-clusters/technologies/regulation-legislation/red.
However, for a variety of reasons, a manufacturer may decide that it must choose option 2, using a Notified Body to obtain a Type Examination Certificate. A manufacturer would be required to develop and test their product to a test plan which addresses all of the RED’s Essential Requirements. These results would then be incorporated into a technical file and submitted to a Notified Body for review and (hopefully) approval. Note that the Type Examination Certificate may expire whenever there is a change to the state of the art, applied standards, or Essential Requirements. Any modifications made to the device by the manufacturer that may affect compliance with the Essential Requirements would also require a subsequent review by the Notified Body.
Obligations of the Manufacturer
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.
Quoting from the EU’s Blue Guide:
“As a general rule, when placing a product on the market, the manufacturer must take all measures necessary to ensure that the manufacturing process assures compliance of the products and in particular:
- Carry out the applicable conformity assessment or have it carried out, in accordance with the procedure(s) laid down by the relevant Union harmonization legislation. Depending on the Union harmonization act, the manufacturer may be required to submit the product to a third party (usually a notified body) to have the conformity assessment carried out, or to have a quality system approved by a notified body. In any case, the manufacturer bears full responsibility for product conformity.
- Draw up the required technical documentation;
- Draw up the EU Declaration of Conformity;
- Accompany the product with instructions and safety information as required by the applicable Union harmonization legislation, in a language easily understood by consumers and other end-users, as determined by the Member State concerned. Unless otherwise specified in specific legislation, instructions and safety information need to be provided, whether the product is intended for consumers or other end-users. This should include all the necessary information for the safe use of the product, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product. Instructions for assembly or installation should include the inventory parts and special skills or tools. Instructions on operation should include information for restriction of use, need for personal protective equipment, maintenance and cleaning or repair. It is for the manufacturer to determine the relevant information which should be included in the instructions and safety information for a particular product. Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product. Furthermore, a tool designed and intended to be used by professionals only might also be used by non-professionals, the design and instructions accompanied must take this possibility into account;
- Satisfy the following traceability requirements:
Keep the technical documentation and the EU Declaration of Conformity for 10 years after the product has been placed on the market or for the period specified in the relevant Union harmonization act.”
The manufacturer is obligated to draw up a DoC for each product placed on the market in the EU. According to the EU’s Blue Guide, the DoC must include at least the following information:
- A [model] number identifying the product. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number. This is left to the discretion of the manufacturer.
- The name and address of the manufacturer or the authorized representative issuing the declaration.
- A statement that the declaration is issued under the sole responsibility of the manufacturer.
- The identification of the product allowing traceability. This is basically any relevant information supplementary to point 1 describing the product and allowing for its traceability. It may [be] relevant for the identification of the product [to] contain an image, but unless specified as a requirement in the Union harmonization legislation, this is left to the discretion of the manufacturer.
- All relevant Union harmonization legislation complied with; the referenced standards or other technical specifications (such as national technical standards and specifications) in a precise, complete and clearly defined way; this implies that the version and/or date of the relevant standard is specified.
- The name and identification number of the notified body when it has been involved in the conformity assessment procedure and the reference to the relevant certificate, if applicable.
- All supplementary information that may be required (for example grade, category), if applicable.
- The date of issue of the declaration; signature and title or an equivalent marking of authorized person
The EU 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. Directions for a simplified DoC as well as the information required in the language of each Member State is available at www.dlsemc.com/EU. This site also includes the definition of “Placing on the Market,” the latest EU Blue Guide and the most recent publications in the Official Journal relevant to the RED, the R&TTE Directive, the LVD and the EMC Directive.
Conclusion
As discussed above, 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.
It should also be remembered that 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 apply to the final product, and the Machinery Directive and the associated standards used would also be listed on the DoC.
