Bringing your radio device to the EU market in 6 simple steps

Radio communication technologies are integrated into almost every electrical and electronic device that we use in our daily lives. Without radio technologies, we wouldn’t have smart phones, networked computers and printers, smart watches and other wearables that track our movement or critical bodily functions, or smart home appliances, thermostats and security systems.

But meeting the regulatory approval requirements applicable to radio modules in the European Union (EU) is not without its challenges. So, here’s a straightforward six step approach that can help you to meet EU regulatory requirements and to bring your innovative connected technologies to market:

1. Define the product 

2. Identify the relevant regulatory directives and regulations

In the EU, the Radio Equipment Directive (2014/53/EU, also known as the RED) establishes the regulatory framework for most types of radio communication equipment intended to be marketed or sold in the EU. Radio communication equipment covered under the scope of the RED include finished devices with integrated radio communication technology, as well as radio modules designed to be integrated as a communications component in a finished device. 

Essential requirements applicable to radio equipment are defined in Article 3 of the RED. In brief, radio equipment must:

1. be constructed to ensure operational safety consistent with the requirements of the EU’s Low Voltage Directive (EU 2014/35/EU);
2. provide suitable levels of electromagnetic compatibility (EMC) as defined under EU Directive 2014/30/EU; and
3. have effective and efficient use of radio spectrum in order to avoid harmful interference with other devices.

Additional essential requirements are applicable to specific categories or classes of radio equipment.

3. Test to demonstrate conformity with the Directive’s essential requirements

4. Prepare the required documentation

5. Complete the conformity assessment process

The RED provides radio device manufacturers with four options for completing the conformity assessment process, as follows: 1) internal production control (Module A); 2) EU-type examination (Module B); 3) conformity to type based on internal production control (Module C); and 4) conformity based on full quality assurance (Module H).

A manufacturer who chooses the Module A option and who demonstrates compliance with the relevant harmonized standards can then self-certify their device by issuing an EU declaration of conformity consistent with the requirements detailed in Annex VI of the RED. However, manufacturers may also choose to work with an EU notified body to verify compliance in accordance with their selected conformity assessment module. If harmonized standards are not available/used or met for the efficient and effective use of the radio spectrum, then an EU Type Examination Certification is mandatory for evaluation of the product for portions (or all, if desired) of the essential requirements.

6. Place the CE Mark on your radio device

The final step in the regulatory process is to apply the CE Mark to those devices that have been found to meet the essential requirements of the RED before placing them on the market. In cases where a device manufacturer chooses the Module H option and uses an EU notified body to conduct the conformity assessment process, the identification number of the notified body is also applied to the device.

It’s important to note that many manufacturers of radio communication technologies do not have either the depth of internal expertise or the testing capabilities to conduct a complete conformity assessment process on their own. In such cases, working with an EU notified body to conduct the requisite assessment and testing of a radio device is the sensible way to ensure compliance with the requirements of the RED while also helping to speed the introduction of new radio devices to the EU market.

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