Today, 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 productThe first step is to define how and where your product is intended to be used, as well as the specific type of radio communications technology you plan to integrate into the product. For example, connected medical devices are subject to greater scrutiny, since radio signals may unintentionally present a direct risk to patients or other medical equipment. Also, your choice of communication technology (e.g., Wi-Fi, Bluetooth, cellular, etc.) will define many of the requirements and the types of testing you’ll need to conduct.
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) minimize the risk of 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
Compliance with the essential requirements of the RED is generally verified by testing to the specifications detailed in harmonized standards published by the EU Commission. To date, the Commission has published more than 100 harmonized standards applicable to various types of radio equipment. The type of device, its planned use, and the radio communication technology used by the device determine which standards should be included in the test plan.
4. Prepare the required documentation
Annex V of the RED details the minimum requirements regarding the technical documentation that must be collected for a radio-enabled device prior to placing it on the market. This includes: 1) a description of the equipment or device; 2) detailed engineering drawings and explanatory text of the device’s components, sub-assemblies and circuits; 3) a list of the harmonized standards that have been used to assess a device for compliance with the RED’s essential requirements; 4) copies of all relevant test reports; and 5) either an EU declaration of conformity or an EU-type examination certificate issued by an EU notified body (see Step #5).
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.
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.