More and more products with wireless connectivity technology are being developed for both consumers and businesses. What do manufacturers need to consider when launching these products in the EU, the US, and Canada?
Whether it is smartphones, smart home appliances, vehicles with GPS, or wireless devices in various industrial environments: More and more products use built-in radio modules to communicate wirelessly with other devices and, in this way, solve a variety of tasks even faster and better. In both the EU and North America, manufacturers must comply with specific regulations to legally sell their wireless products, and the requirements in the European and North American markets differ.
Requirements for wireless modules in the European Union (EU)
In the EU, wireless products must comply with various directives, specifically the EMC Directive and the Radio Equipment Directive (RED). These directives define a number of technical requirements.
Radio modules built into radio products must conform to the relevant directives and be labeled by the module manufacturer following the directives and bear the CE marking. Therefore, it is not sufficient that only the final radio product has a CE marking, and the installed module must have its declaration of conformity (DoC) and CE marking.
What requirements do the relevant directives define? The RED includes radio performance, EMC performance and product safety (including RF exposure) assessments for all equipment containing a radio function, transmitter or receiver.
Module manufacturers must test their equipment for all of the above and then draw up a declaration of conformity and affix a CE marking. The CE marking of the radio module is a declaration by the manufacturer that the radio module complies with the RED Directive. The installation instructions and the DoC of the radio module describe under which conditions this applies. In addition, specific devices require an EU type-examination certificate from an EU Notified Body before being placed on the market. In these cases, the EU type-examination certificate is a prerequisite for drawing up a valid declaration of conformity; the type-examination certificate alone is not a product approval document.
To place a radio product on the market, it is not sufficient that the installed radio module has a DoC and CE marking. The entire product itself, as a transmitter product, is also subject to the RED safety requirements. The final product manufacturer bears sole responsibility for drawing up a declaration of conformity and affixing a CE marking to the final product.
Requirements for radio modules in the USA and Canada
The steps for market access of radio modules in North America differ from those in the EU. The authorities FCC (Federal Communications Commission) in the USA and ISED (Innovation, Science and Economic Development Canada) in Canada monitor compliance with the requirements. In the process, the products receive an FCC ID or ISED certification number and have to be registered by the authorities, stating various technical specifications. A unique feature that distinguishes the process in North America from that in the EU is the so-called modular approval specifically for radio modules. In this procedure, manufacturers of radio modules are not obliged to certify the module for use as a stand-alone radio device. Still, only the final device in which the module is installed requires certification. However, depending on the intended use, specific tests are still needed. Once the process is complete, the manufacturer then marks the module with "modular approval".
The radio module must have a shield inside over the transmitter part to reduce coupling between the module and the host to obtain modular approval. Furthermore, voltage regulation is required to be able to supply the transmitter part independently of the host. If the above points are not met, it is possible to obtain "limited modular certification". In this case, the module must be tested and inspected together with the host. Even more important than the test report of a radio module is its installation instruction, especially concerning the antenna. The tests for FCC and ISED approvals are based on the emissions of the transmitter, such as EMC emissions or risks of RF exposure.
Suppose a manufacturer uses such a modular certified radio module for a device. In that case, he does not have to have the module tested again for conformity because the radio module manufacturer has already done this. However, the device or product in which the module is installed may still need its approval. The manufacturer of the final radio product is responsible for ensuring that the product passes any FCC and ISED transmitter tests required. These may include but are not limited to an EIRP measurement and a test for spurious emissions. In North America, transmit power, EMC emissions, and RF exposure are relevant factors in meeting safety requirements.
Suppose a manufacturer installs a radio module in his device, and the label of this module is no longer visible to the user. In that case, the manufacturer must label the end product on the outside. Writing "Contains FCC ID: XXXXX" or "Contains IC: YYYY-YYY" on the device label will explain this fact. XXXXX stands for the FCC ID and YYYY-YYY for the ISED certification number of the radio module. The module’s FCC ID and ISED certification number do not automatically guarantee that the final radio product meets the technical test aspects of the FCC or ISED specifications. It needs to be ensured in separate tests of the final product.
Source: Derby, Michael, ACB Europe Ltd.: „Radio Enabled Products using Radio Modules. “