Radio Equipment Directive risk assessment confusion
(Updated on 30 June 2017)
Radio Equipment Directive risk assessment confusion With the world going wireless, radio equipment covers an ever growing variety of products, driven by the growth of mobile devices and wearable applications aiming to increase our levels of connectivity.
As of 13th June 2017, the new European Union Radio Equipment Directive (RED) 2014/53/EU fully repealed the old Radio and Telecommunications Terminal Equipment Directive (R&TTE) 1999/5/EC. This means that radio equipment conforming to the R&TTE Directive must now conform to the RED, before being placed on the market within the European Union (EU). Manufacturers intending to market radio products within the EU and European Free Trade Association (EFTA) countries must ensure that the radio products comply with the requirements of the RED. Products that were already compliant with R&TTE requirements may be subject to additional testing in order to comply with any changes.
The RED clarifies the responsibilities and obligations for every economic operator involved in the supply chain (manufacturer, importer, distributor, authorised representative). The Directive is applicable to all electrical and electronic devices that intentionally emit and receive radio waves at frequencies below 3000 GHz
Under the RED, this is the first time that broadcast receivers (satellite, TV and radio) are subject to radio compliance requirements in relation to the use of the radio spectrum. Whereas products were previously only required to comply with the requirements of the EMC and Low Voltage Directives. Consequently, many broadcast receiver manufacturers are now subject to radio compliance undertakings for the first time.
This is also the first time that equipment operating below 9 kHz are required to demonstrate radio compliance as the RED scope covers radio equipment operating below 3000 GHz, whereas the R&TTE scope started at 9 kHz.
New risk assessment requirement
Both the requirements and the types of products that fall under the RED have changed compared with the R&TTE, and so establishing compliance is a significant challenge for many manufacturers.
A critical change for the RED compared with the R&TTE is that the RED conformity assessment procedures require that the technical documentation includes an adequate analysis and assessment of the risk(s). Although manufacturers have experienced approvals managers, they are not familiar with a risk-based approach and therefore may not have the appropriate knowledge or skillset to meet this requirement. This is causing confusion and presenting new challenges for manufacturers, when demonstrating compliance with the essential requirements of the RED.
Many manufacturers are struggling to become fully cognisant of the changes which the RED has introduced as there is no prescribed risk assessment methodology. It is instead referenced in a new common legislative framework that is based on legislative harmonisation by the adoption of specified directives that set essential requirements. These ‘essential requirements’ are mandatory for products intended to be place on the EU market. ‘Risk’ relates to the risk of non-compliance with the applicable essential requirements.
The risk assessment process means that manufacturers must consider a lateral compliance strategy, which not only considers harmonised standards but also any risks for non-compliance that may not necessarily be covered by the applications of standards alone. The assessment must therefore analyse the risks and demonstrate how they are reduced, so that the equipment can be deemed to comply with the essential requirements.
Manufacturers should present the risk assessments in a format that is suitable to them. Reducing complexity in risk assessments is very important, so that the focus is not removed from showing how the equipment is compliant. A tabulated or spreadsheet format may promote easier risk assessment writing and reading, but a risk assessment can be presented on any format.
However, there is a minimum amount of information that should be included for a risk assessment to be considered adequate. It should primarily consider the intended use of the radio equipment, as outlined in the equipment’s instructions and, for the health and safety essential requirement, the reasonably foreseeable use. ‘Foreseeable use’ is quite subjective, so a reasonable consideration should be made according to the product type, environment and users.
To demonstrate compliance, the aim is to reduce risks as far as practicably possible. The risk analysis and assessment would include the identification of applicable essential requirements, and the selection of appropriate harmonised standards or other specifications as risk reduction measures. The assessment should also include a conclusive statement which confirms the radio equipment’s overall compliance as a result of the risk assessment.
Collective guidance on general risk assessment methodology, from the European Commission and the Administrative Co-operation (ADCO) working group, consider the following for risk assessments:
Product Definition - identify radio and non-radio functions and features, together with labelling information and instructions for use. Associated accessories or components should also be identified.
Risk Identification – identify the hazards and subjects at risk in relation to all essential requirements
Risk Subjects – clarify the subjects at risk e.g. types of person, equipment and radio spectrum users
Harms – consider how the hazard may harm the subjects at risk and what the potential harms are.
Risk Level – consider the probability and severity of harm in combination to determine a specific risk level for the hazard being assessed.
Risk Reduction – reduce/mitigate the level of risk to demonstrate how the individual risks are controlled to compliant levels.
Controlled Risk Evaluation - once risks have been reduced, re-evaluate the risk level to conclude the analysis and assessment of risks. The overall conclusion of the risk assessment aims to establish compliant levels of risk.
Continual process Risk assessment should be instigated at the start of the conformity assessment process, and not at the end, as many manufacturers may previously have done. Compliance risk management is a continual process, and the manufacturer must re-analyse and re-assess the risks with every product modification. Where compliance is deemed to be potentially affected, risk control measures should be demonstrated and documented in the technical file before updating the declaration of conformity and/or EU-type examination certification as appropriate.
The RED’s wide ranging changes are requiring some significant adaptations to how radio equipment is manufactured and supplied. It is therefore vital that manufacturers, and those within their supply chain, understand and comply with their specific obligations. This will ensure that their equipment complies and can continue to be sold on the European market.
How can TÜV SÜD help you?
TÜV SÜD can provide access to TÜV SÜD BABT, one of the world’s leading independent certification bodies for telecommunications and certifies wireless products for the European Union, USA, Canada and Japan. As an EU Notified Body, TÜV SÜD BABT is authorised to evaluate products for compliance with the requirements of the RED and approve the use of the CE Mark.
TÜV SÜD also offers a Global Market Access (GMA) service, which helps you to manage the challenge of product compliance against diverse national requirements. We can deliver one-stop compliance solutions for most wireless communications products, helping you to meet the requirements of Europe’s new RED, as well as streamline exports to other markets worldwide.