Getting radio equipment directive risk assessment right
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 otherwise they can no longer be placed on the market. It is therefore crucial to fully understand these regulatory differences in order to avoid time and cost overruns. Products that were already compliant with R&TTE requirements may be subject to additional testing in order to comply with any changes.
The RED’s new requirements are intended to clearly spell out 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. This is therefore the first time that equipment operating below 9 kHz is required to demonstrate radio compliance, as the R&TTE scope started at 9 kHz.
A significant change is that radio broadcast and TV receivers are no longer excluded from the scope of the directive. Previously such products were required to comply with the EMC and Low Voltage Directives as they were specifically excluded from the old R&TTE Directive. Consequently, many manufacturers, such as those in the automotive industry, are finding achieving compliance to be a significant challenge as they have never before been required to undertake RF testing.
The following definition explains what products are subject to the RED: “Radio equipment – an electrical or electronic product which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory (such as an antenna) so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination.”
Taking a new approach to risk assessment
Another key change, which still seems to be causing confusion a year on from the RED’s introduction, is that the conformity assessment process now requires a manufacturer to undertake a risk analysis and assessment. Many manufacturers are still failing to become fully cognisant of these changes, as there is no explicit description of the risk assessment process within the RED, it is instead referenced in the EU’s New Legislative Framework. The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C 272/01) for the New Legislative Framework contains important risk guidance. ‘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. Where manufacturers may be familiar with more obvious health and safety risks for a product for the RED Article 3.1a essential requirement, an RED risk assessment needs to identify compliance risks to all applicable essential requirements. This includes Article 3.1b Electromagnetic Compatibility (EMC), Article 3.2 Radio Spectrum, and where applicable Article 3.3.
The risk assessment can be presented in any format, but it is important to remember to keep it simple, so that the focus remains on showing how the equipment is compliant. For example, a tabulated or spreadsheet format may promote easier risk assessment writing and reading.
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.
An adequate risk analysis and assessment should therefore cover:
- 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.
- How the hazard may harm the subjects at risk.
- The potential harm.
- The likely severity of harm – the foreseeable level of harm to the subject and probability must be assessed to determine the level of risk.
- Risk reduction/mitigation – demonstrate how the individual risks are controlled.
- Controlled Risk Evaluation – once risks have been reduced, re-evaluate the risk level.
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.
Back to the beginning
Risk assessment should be instigated at the start of the conformity assessment process, and not at the end as many manufacturers that are more used to complying with the R&TTE 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.
European Standards Organisations (ESOs), European Telecommunications Standards Institute’s (ETSI) and CENELEC have developed Harmonised European Standards, which are the preferred means for manufacturers to comply with the RED.
The European Commission has published several Harmonised Standards lists for the RED in the Official Journal (OJ) and is updating it as necessary. Due to the complexity of developing new standards not all radio technologies will have OJ cited RED harmonised standards available.
In the absence of ETSI RED Article 3.2 and 3.3 standards published in the OJ, it is mandatory for any manufacturers wishing for an early implementation of the RED to apply to a Notified Body for a Type Examination Certificate or a Full Quality Assurance Approval.
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. The RED also introduces a range of new responsibilities for the entire supply chain, including manufacturers, importers and integrators of radio equipment. This includes responsibility for product traceability, risk analysis and assessment, sample testing, and a register of complaints and product recalls. The RED has also changed who is responsible for re-branded equipment within the supply chain. For the first time, importers and distributors take on the responsibilities, which were once those of the original manufacturer, where radio equipment is re-badged and supplied under their own name or trade mark.
These new wide ranging changes are requiring some significant adaptations to how radio equipment is manufactured and supplied. It is therefore vital that the entire supply chain understands and complies with their specific obligations. This will ensure that their equipment complies and can continue to be sold on the European market.
About the author
Jon Lea is a RED Senior Product Specialist at TÜV SÜD Product Service, a global product testing and certification organisation, and at its sister company, TÜV SÜD BABT, the world’s leading radio and telecommunications certification body.
TÜV SÜD Product Service is one of the leading experts in product testing and certification, with 150,000 product certificates in circulation globally. TÜV SÜD Product Service analyses over 20,000 products each year in Europe, Asia-Pacific and the Americas, ensuring that products are safe, reliable and compliant and minimising liability risks for manufacturers, importers and retailers.