• Radio Equipment Directive (RED): Guide for EU Importers

    Posted on Leave a comment

    Wireless headset

    Try our Product Compliance Software Tool Here

    The Radio Equipment Directive 2014/53/EU (RED) covers WiFi, Bluetooth, RFID, LTE, 5G, GPS devices. As such, it’s applicable to everything from wearables and tablets to smart home devices and wireless headsets. In this guide, we explain what importers and manufacturers must know about RED – including standards, CE marking, documentation, testing, and more.

    What is the Radio Equipment Directive (RED)?

    The RED is an EU directive for placing radio equipment on the EU market. It sets out the essential requirements such as the safety of individuals, domestic animals and property, electromagnetic compatibility, and efficient use of the radio spectrum. The directive also specifies additional requirements for certain product classes:

    1. Ensuring efficient use of the network, in order to avoid degradations of service

    2. Ability to protect the personal data and privacy of the user

    3. Supporting anti-fraud features

    4. Ensuring access to emergency services

    5. Ability facilitate the use by users with a disability

    The directive defines radio equipment as any electronic product that intentionally emits and receives radio waves for the purpose of radio communication and radio determination. Therefore, the RED is applicable to the wide range of electronic products that are Wi-Fi, Bluetooth, LTE, 5G, or GPS enabled.

    What is the difference between RED and R&TTE?

    The Radio and Telecommunications Terminal Equipment Directive (R&TTE) is a former EU directive that covered safety and electromagnetic compatibility aspects of radio equipment. In 2016, the RED came into force, replacing the R&TTE Directive. Even though both directives broadly cover the same aspects, there are some major differences between the two:

    1. Radio equipment covered by the RED is not subjected to the Low Voltage Directive, as the RED also covers the electrical safety aspects. This is also the case with the EMC Directive, as the RED fully covers electromagnetic compatibility aspects.

    2. The RED requires ‘more efficient’ use of the radio spectrum

    3. The R&TTE Directive used to cover wired telecommunication terminals, but it is now taken over by the LVD and EMC directive. The RED only covers radio-enabled terminals.

    4. Broadcast TV and radio receivers fall into the scope of the RED, while these were not covered by the R&TTE Directive.

    5. Radio equipment operating at frequencies below 9 kHz is covered by the RED, while it was not covered by the R&TTE.

    Note that any radio equipment placed in the market after June 2017 shall comply with the RED requirements, even if it complies with the R&TTE Directive.

    Products covered by the Radio Equipment Directive (RED)

    The RED covers radio equipment operating at frequencies below 3,000 GHz. This includes Wi-Fi, LTE, 3G/4G/5G, GPS, active RFID, and Bluetooth enabled devices. Here are some product examples:

    Product Exemptions

    Annex I of the RED specifies exempted products, including:

    • Amateur radio kits
    • Marine radio equipment
    • Airborne related products
    • Custom-built kits for R&D evaluation

    EN Standards

    The European Commission provides a list of harmonized standards applicable to a wide range of products that fall into the scope of the Radio Equipment Directive (RED).

    EN 55035 – Electromagnetic compatibility of multimedia equipment

    EN 55035 specifies electromagnetic immunity requirements for a wide range of consumer electronic products, including audio and video equipment, and broadcast equipment. The standard include both test methods and limit values.

    EN 50360 – Product standard to demonstrate the compliance of wireless communication devices

    EN 50360 is applicable to wireless communication devices ranging from 300 MHz to 6 GHz such as mobile phones and wireless headsets. It provides the basic restrictions and exposure limit related to the electromagnetic fields, mobile communication systems, telecommunication systems, and mobile radio systems.

    EN 300 422 – Wireless Microphones; Audio PMSE up to 3 GHz

    EN 300 422 covers the technical requirements, testing methods, and limits for transmitter parameters of wireless microphones and related equipment.

    EN 301 357 – Cordless audio devices in the range 25 MHz to 2 000 MHz

    EN 301 357 covers cordless audio devices that fall into the scope of the RED. It specifies testing requirements such as external frequency control test, integral antenna test, and internal RF test.

    EN 300 220 – Short Range Devices (SRD) operating in the frequency range 25 MHz to 1000 MHz

    EN 300 220 covers technical characteristic and test method of short-range devices equipment range 25 MHz to 1 GHz, such as CCTV, gate openers, movement detectors, and remote control. Also, it provides the required technical performances of the test equipment such as spectrum analyzer and signal generators.

    EN 300 328 – Wideband transmission systems

    EN 300 328 is applicable to Wide Band Data Transmission equipment such as Bluetooth wireless technologies, Zigbee, and more. It sets out the technical requirements specifications including modulation and equipment types. Also, it provides the conformance requirements of RF output power, accumulated transmit time, hopping frequency separation, and others.

    EN 302 065-1 Short Range Devices (SRD) using Ultra Wide Band technology (UWB)

    EN 302 065-1 applies to transceivers, transmitters, and receivers using UWB technologies for short-range applications. It specifies the testing methods needed to comply with technical requirements, conformance test suits, and technical requirements specifications. Also, it includes the measurement of antenna, preamplifier, and cable specifications.

    Documentation

    The goal of the documentation is to demonstrate compliance with the requirements, allow traceability, and inform the user on how to use the product. In this section, we list some essential documents that importers and manufacturers shall prepare before placing the product into the market.

    Declaration of Conformity

    Manufacturers and importers shall prepare an EU Declaration of Conformity (DoC) for each product (SKU) and support the DoC with the relevant technical documentation. Annex VI of the directive provides the information that must be included in the DoC.

    Product description

    The DoC must include type, batch, serial number, or other relevant information about the product. You can also include product photos in the DoC. Note that the SKU/Model number must match what is specified in all support documents, such as the technical file, lab test report, and user manual.

    Manufacturer or importer contact information

    Include the importer or manufacturer name, address, phone number, or other available information for direct contact.

    Compliance statement

    Include a statement declaring that the product is made in compliance with the relevant regulations and directives, such as Directive 2014/53/EU).

    List of harmonized standards

    Specify which standards (e.g. EN 55035 – Electromagnetic compatibility of multimedia equipment) have been applied to ensure product compliance.

    Notified body information ( if applicable)

    If you have appointed a notified body for the conformity assessment, then you shall also include the notified body details in the DoC, including their body, 4 digital notified body number, and the reference number of the certificate.

    EU-type examination certificate information (if applicable)

    Importers shall also attach their EU-type examination certificate if applicable. You must list all certificates obtained and include the certificate number and reference number.

    Signature and date

    The manufacturer or importer shall sign and date the Declaration of Conformity.

    User Manual

    Providing a user manual is mandatory for all products covered by the Radio Equipment Directive (RED). This information is generally included:

    • Product description
    • Product installation procedure
    • Product intended use
    • Component and accessories details
    • Safety instructions and safety assessment
    • Frequency band(s)
    • Maximum radio-frequency power transmitted
    • Compliance marks (ie. CE, WEEE)

    Technical File

    Importers and manufacturers shall also create a technical file containing relevant data and details of the radio equipment. The RED provides the content element of a technical file in Annex V, which includes:

    General description of the radio equipment

    The general description shall include the intended use, device features, components, batch ID, and other relevant information to describe the equipment. This should match the information provided in the DoC, user manual, and test report.

    Drawings/Design Files

    The drawings require more than just a general description. The file shall include all relevant drawings of the radio equipment such as wiring diagram and design files. Here are some examples:

    • Wiring diagrams
    • Casing CAD files
    • ISO design drawings
    • Packaging design
    • Photocopies
    • User manual files

    Component List

    Include each electronic components’ schemes, such as drawings, sub-assemblies, circuits, and other similar elements. You should also include the component list (bill of materials).

    List of applied harmonized standards

    Similar to the DoC, importers shall also include a list of applied harmonized standards in the technical file.

    Test reports

    Test reports are necessary as a way to demonstrate that the product is verified as compliant.

    EU Type-Examination Certificate

    The involvement of a Notified Body is required if you for some reason don’t apply harmonized standards to ensure compliance with the requirements covered in RED. This in turn requires that you must obtain an EU Type-Examination Certificate. That said, this is not necessary for most products as there is a wide range of published EN standards to apply.

    Authorised Representative

    Non-EU based companies that plan to sell their products directly in the European Union must appoint an Authorized Representative. This also requires the packaging to carry the address and contact details of the appointed Authorised Representative. The duties of the Authorised Representative duties include:

    • Authorization to place its address on the packaging
    • Acting as a contact point for the authorities
    • Assisting during the draft of the technical file
    • Retaining the conformity documentation for 10 years

    Labeling Requirements

    In this section, we cover the essential labeling requirements for products covered by the Radio Equipment Directive (RED).

    CE Marking

    CE Mark

    The CE mark indicates conformity with all applicable requirements when importing and selling in the EU market. As such, the CE mark shall be permanently affixed to the product and its packaging. This is mandatory for all products covered by the Radio Equipment Directive (RED). You can download CE mark files on the EU official website.

    Product Traceability

    The RED requires importers and manufacturers to ensure product traceability throughout the whole supply chain. As such, the following information shall be permanently affixed in the product or its packaging (when the device is too small to include all the information):

    • Company name
    • Company address
    • SKU/Model number
    • Batch ID

    The contact details shall be in a language that can be understood by surveillance authorities or consumers.

    Lab Testing

    As already mentioned, lab testing is an essential step to assess compliance with the RED. Here a brief list of companies that offer testing, certification, and other related services for the RED:

    • SGS
    • Intertek
    • TÜV
    • Element

    You can find more RED testing companies in this article.

    Compliance Risks

    Electronic products manufactured outside the European Union are not exclusively designed to comply with EU regulations such as the Radio Equipment Directive (RED). On the contrary, many electronics manufacturers in China, and other countries, are not even aware of RED and its requirements.

    Ensuring compliance with the Radio Equipment Directive (RED) requires a hands-on approach that takes the following steps into consideration:

    • Confirm applicable EN standards
    • Create Declaration of Conformity (DoC)
    • Create Technical File
    • Create User Manual
    • Book third-party lab testing

    It’s rare to find suppliers in China, and other countries, that can provide pre-existing test reports and other mandatory documents. This doesn’t necessarily mean that a supplier lacks the capability to manufacture products according to the requirements outlined in the Radio Equipment Directive (RED). What it does mean, however, is that you can never take for granted that a certain product is compliant – and even if so is the case, you still need to create label files and documentation.

  • Generate a PDF with EU & US compliance requirements for 21 product categories

    Compliance Tool
    Learn more here

    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
  • Leave a Reply

    Your email address will not be published. Required fields are marked *

    [i]
    [i]