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By Steve Hayes and Michael Derby

The Radio Equipment Directive (RED) – 2014/53/EU, like other EU Directives and UK Regulations, requires the manufacturer to perform an adequate analysis and assessment of the risks, with regard to compliance.

What does 'risk' mean in the context of the Radio Equipment Directive (RED)?

The RED mandates that manufacturers consider the following essential requirements: 

• Article 3.1(a) – The protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in Directive 2014/35/EU, but with no voltage limit applying
• Article 3.1(b) EMC – An adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU
• Article 3.2 – Radio equipment shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference
• Article 3.3 – Radio equipment within certain categories or classes shall be so constructed that it complies with other designated essential requirements (not applicable to all radios).

The Radio Equipment Directive (RED) requires equipment manufacturers to perform an assessment of their product to essential requirements: safety, EMC, and radio, and in some cases, other categories may also apply.   Most manufacturers understand this to mean that they test to some standards and then create their Declaration of Conformity (DoC) to show that they meet the Directive.

In addition, there is a requirement for manufacturers to perform an analysis of the risks associated with the radio equipment and its compliance with the RED. It is important to remember that the manufacturer assesses their product to test standards, but the DoC they sign states compliance with the Directive. This analysis of risks that the manufacturer must perform is often referred to as the manufacturer's risk assessment, and it must be available for the manufacturer to show to a market surveillance authority or to a Notified Body, if the manufacturer is asked to provide it.
It is an essential document and a very important part of the manufacturer's technical documentation, but what exactly is it, and what should it contain?

There is no template or clear list of what must appear in the manufacturer's risk assessment. Manufacturers will all have their own approach to this, for their own unique products. However, this document provides you with the basic idea of the risk assessment and offers some guidance on what you should consider.

Firstly, the manufacturer's risk assessment for the RED may not be a traditional risk assessment, as is often performed during a safety assessment, with a neat graphical table showing the severity of consequences compared to the likelihood of a risk happening. Instead, the compliance risk assessment performed by the radio equipment manufacturer is more of a supporting document and a tool used by the manufacturer to ensure they have thought of everything before signing their DoC.

When planning to develop a product that will be placed on the market in the EU, the compliance risk assessment would typically be the first document the manufacturer opens and the last one they close. It is not expected that the risk assessment is a document thrown together at the end.

Ensure that the product can be used in the region

The first stage of compliance planning ensures that a product can be used in the intended region.  Placing radio equipment onto the market in the EU requires that it can be operated in at least one EU member state, so the evidence of this would be the starting point of the risk assessment.

Once it has been established that the equipment can be placed on the market in the EU, and it has been determined which EU member states will allow the equipment, the next step is to identify how to assess the radio to the essential requirements of the RED.

Determine the relevant standards

The most common and recommended compliance route is to apply test standards to the equipment. Therefore, the next step in the risk assessment is to begin identifying which standards apply to the radio equipment. It is quite likely that multiple standards may apply to a single radio equipment. It is essential to identify which ones apply, and which test cases are applicable.

For product safety, Article 3.1a of the RED, the selection of standard may depend on the type of equipment, the intended environment, or a combination of these factors. Test and measurement equipment may not require the same assessment as a multi-media device. A multi-media device for use in the home or office may not require the same evaluation as a multi-media device in a medical environment. A radio transmitter may require an RF Exposure assessment based on a combination of output power and distance from the body in regular use.

For Electromagnetic Compatibility (EMC), Article 3.1b of the RED, the selection of standards and test cases may depend on the type of equipment, the modes of operation, the environment for use, and the user's expectations. Many modern IoT or other radio equipment will have more than one function, and therefore, multiple EMC standards will likely apply. The individual test cases may be similar, but the requirement to monitor and evaluate the performance may vary per mode or operation.

For radio performance, Article 3.2 of the RED, the selection of standards and test cases may depend on the type of radio communication included in the equipment and how it is intended to operate. If the equipment contains multiple radio types, it is likely that there are standards for each radio within it but not for the combination of radio equipment operating simultaneously.

For other categories, Article 3.3 of the RED, the requirements are in development for many types of equipment, and not all of these requirements will apply to all types of radio equipment.

Choose the correct combination of standards

For all of the above Articles, the correct combination of standards and test cases will need to be identified and documented in the risk assessment by the manufacturer. If multiple standards apply, the document will show that all applicable standards have been identified and that the manufacturer didn't just stop searching as soon as they found one reasonable standard per Article of the RED.

In the case of harmonized standards listed on the Official Journal of the EU (OJEU), the manufacturer would use their risk assessment to document their choice of standard and identify any known date of withdrawal from the OJEU.

In the case of standards not listed on the OJEU (known as non-harmonized standards), the manufacturer must document their choice of standards on their risk assessment, including a justification of why they selected that standard and why they think it is suitable to demonstrate compliance with the RED. If the standard is not harmonized, it may lack some critical information, or it may not provide enough scope to cover the RED; then the risk assessment would be used to identify and record what additional assessment is needed to overcome the shortcomings of the standard.

Identifying compliance risks not covered by the standard

The next step is for the manufacturer to ask themselves the question: "Is there anything about my product that has not been covered by those standards?" Meeting the standards is a great way to have confidence of compliance, but the purpose of this risk assessment is to identify any other compliance risks that may exist but were not covered by the standards. For example, EMC and radio test standards are typically written around the most common or expected requirements and are often based on historical experiences. An EMC immunity test and a radiated emissions test may be detailed in the test standard to be performed on equipment over the range of 150 kHz to 6 GHz.   However, if the manufacturer suspects that their equipment could be susceptible to interference outside of that range or may emit and cause interference outside of that range, the risk assessment would be the place for the manufacturer to identify that risk and decide that additional testing is necessary. The manufacturer would then assess their product over the more appropriate range.

Also, the risk assessment is generally used to help match the specifics of their product to the details of the standards.

The manufacturer would use their risk assessment to evaluate the intended environment for their radio equipment. Examples would include a medical environment, automotive environment, industrial, outdoors without weather protection, and conditions such as extremes of temperature, extremes of altitude, variations in input voltage, all of which may not be adequately covered for their equipment within the general approach of the test standard. Another part of the environment could be that multiple radio technologies have been combined, which may be known by the manufacturer but may not be covered within each technology-specific test standard.

The test standards are typically based on testing a piece of equipment in its intended condition, but this is the time for the manufacturer to understand exactly what that means. If cables are supplied with the equipment, research may be needed to determine the worst configuration to test. If cables are not supplied, research may be required to ensure that the equipment will continue to comply, regardless of which cable the user chooses to connect. The risk assessment will be used to document the choice and configuration of accessories, such as cables, power supplies, peripherals, etc.

Safety assessments or safety testing are typically risk-based in general. The manufacturer's risk assessment would be used to determine if the safety standard does indeed cover all the health or safety risks that could be presented by the equipment, including any reasonably foreseen use. An example here could be the acoustic safety of equipment with a headphone socket, such as a laptop, where a user could sit for hours and listen to music at their desk.

Several standards require the manufacturer to inform the test lab of critical information about the equipment, such as the worst-case user distance for RF Exposure assessments, the user's expected performance for EMC immunity testing, and the number of modes the equipment supports. The test lab may not know these details about every product without clear input from the manufacturer. The manufacturer may use their risk assessment to determine such information before communicating it to the test lab.

Ensure the user or installer cannot modify the equipment

It is important that the manufacturer supplies compliant radio equipment to the EU market. The user or installer should not be able to modify it to create a non-compliant product, perhaps by changing settings, updating software, or selecting non-EU country regions. The risk assessment would be a good place for the manufacturer to document how they control such things and ensure that only compliant settings or software versions are available on the market.

It is possible that the radio equipment has been created by the installation of radio modules, such that some of the test results are taken from the radio module itself and not re-tested on the final complete product.  In that case, a lot of new information will be needed for the risk assessment. Guidance exists, but there is not a clear list of definitive tests which must or must not, be performed on equipment when installing a radio module. The choice of which tests to perform at the final equipment level and which tests to trust from the radio module is ultimately the manufacturer's decision, where the manufacturer is the company that installs the radio module and supplies the final equipment to the market.  The manufacturer's risk assessment will document and justify the decision to accept any test data from the radio module results. Installation of radio modules into host equipment can be a time-saving solution, but the interaction between module and host can change the radio emissions and receiver performance. In addition, the EU RED compliance is based on an assessment of the final radio equipment, so the installer would need to ensure that the module is assessed to the appropriate standard version number, based on the date of placing the final piece of radio equipment on the market.

Ensure your radio equipment remains compliant

Finally, the radio equipment is expected to remain compliant on the market in any reasonably foreseeable use condition. Therefore, the manufacturer must do all they can to understand how their equipment will be used, based on their intended use for the product, and how people will actually use it.

All of this is typically followed by a trip to the test laboratory, to apply all those test standards and receive evidence of compliance to the standards, in the form of a test report.

When you have your test reports and have reviewed them, it's time to determine if the results and your compliance margins are good enough to give you confidence that the units you supply to the EU market will comply. A manufacturer is expected to know their quality system and manufacturing tolerances, such that they have an idea if they have a good enough pass margin to be confident that the production units will comply. A copy of (or link to) the signed DoC will go out with every unit supplied to the market. There is also a requirement for the manufacturer to perform sample testing while supplying radio equipment to the market, so the risk assessment may be used to determine how detailed and how frequent that sample testing should be.

For the manufacturer, the decision to sign the DoC should be based on test results, pass margin, the full equipment assessment, and the decisions made along the way, as detailed in the risk assessment.

If the manufacturer makes changes to their equipment, modifies the hardware or software, sources new components, changes factory, etc., then it's time to re-open the risk assessment and make some new decisions. If the test standards change, the risk assessment is the place to document the gap analysis and what new assessments or partial testing may be necessary to keep up with the latest standards.

It is always the responsibility of the manufacturer to create and maintain their risk assessment, and that responsibility cannot be transferred to any other company.
At Element, we understand this process, and our experts are here to help you understand the requirements and apply them to your own product and your compliance documentation.

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ÌÇÐÄlogoÃ×·ÆÍÃworks in partnership with manufacturers of radio equipment, such as wireless IoT, and connected technology in a wide range of industry sectors, including the home and consumer market, multi-media and IT, Medical, Industrial, Automotive, and Aerospace markets.

We provide expert guidance from initial product conception onwards, supporting successful product launches and providing tailored advisory, training, testing, and certification services. Our technology experts guide you through the whole product life-cycle, enabling you to feel in control to get your products to market quickly, smoothly, and efficiently.

Contact our experts to learn more about your radio risk assessment.