A New European Union Directive Approach for Radio Equipment

Flag of European Union“Progress is impossible without change, and those who cannot change their minds cannot change anything.” – George Bernard Shaw

The current European Union (EU) Directive for Radio and Telecommunications Terminal Equipment (R&TTE), was originally adopted by the European Commission (EC) in 1995, almost two decades ago. As I am sure you have noticed, there have been a multitude of engineering advances in radio and telecom devices in that time, and the industry stakeholders have been clamoring more and more for a major overhaul of these requirements, to ensure that compliant products utilizing the latest technologies are safe for consumers, and are efficiently and quickly brought to the EU market countries, without undue or unnecessary regulatory hurdles.

A different EC regulatory effort, started by the EU member states about fifteen years ago, was driven by a desire to institute a better way to make laws, by identifying all of the parties that were involved in the entire lifecycle of products placed into the EU marketplace, so specific roles and tasks could clearly be assigned to each. Other drivers included the need to clarify the definition for placing products on the market, the need for more robust market surveillance methods and activities, and clarification on the responsibilities of the national regulatory compliance authorities.

These two forces resulted in the release of a new Radio Equipment Directive (RED) this year, which will be replacing the R&TTE Directive over the next few years, so it is important for manufacturers, product developers, and all other interested parties to start preparing for this change. We’ll first look at the changes that have been made to the EU law-making processes and guidance, then look at the new RED, and how all the different groups will need to transition and adapt to the new regulatory landscape.


A New Framework for EU Legislation

Right around the millennium, the EC was able to obtain agreement from all of the EU member states for an initiative to perform a thorough review and extensive update of the regulations that were in place. The results of these efforts came in 2008, with the adoption of Regulation 765/2008/EC, which set the requirements for accreditation and market surveillance related to marketing of products in the EU, consolidated the meaning of CE marking, and at the same time repealed and replaced the previous Regulation 339/93/EEC, and Decision 768/2008/EC, which established a common framework for the marketing of products in the EU by harmonizing and consolidating the various directives with common definitions, conformity assessment procedures, conformity assessment bodies notification criteria, economic operator responsibilities, and rules for CE marking, and at the same time repealing and replacing the previous regulation Decision 93/465/EEC. Together, these two pieces of legislation established the “New Legislative Framework” (NLF), which provided all of the necessary elements for a robust and comprehensive regulatory framework.

One of the main pillars of the NLF is to ensure that the definitions and obligations of all of the “economic operators” are clarified; economic operators is the term used in the NLF for commercial business stakeholders such as manufacturers, authorized representatives, distributors, and importers. An emphasis is placed on the roles and responsibilities of the manufacturers and importers, as they are seen as the two groups that are the most accountable for any issues resulting from the placement of products into the EU.

A second NLF pillar can be seen in the comprehensive measures incorporated to trace the product supply chain, identifying all of the economic operators in the whole process, and their relation to the product and to each other. One key change is that the manufacturers and importers must provide more information to aid in their identification and contact by customers and other stakeholders.

Another NLF focus can be seen in the consideration given to the entire product life cycle, “from cradle to grave,” to enhance the market surveillance activities. This is being done to help prohibit non-compliant or risky products being placed in the EU. To support this, the responsibilities for all of the national authorities are clarified and defined, recognizing the variety of activities of the different groups, including regulatory authorities, notification authorities, national accreditation entities, market surveillance bodies, and importation agencies.

An additional key change is the legislative emphasis for EU market access. What is currently defined as “placing on the market” has changed in the NLF to the first “making available on the market” of a product in the EU. “Placed on the market” was defined as when it is made available for the first time on the EU market, so this created some ambiguity with those that thought this implied when it was first placed for sale, and some manufacturers would send product samples to customers for free, before it had been tested for conformity, since it wasn’t yet placed on the market for sale. The NLF removes this ambiguity with the phrase “made available on the market,” which is defined as when it enters the EU, whether it is supplied for distribution, consumption, or use on the EU market in a commercial activity, whether it is sold or is given away for free no longer matters; if you bring it into an EU member state, it must be in conformity with a full technical construction file and CE Declaration of Conformity to the applicable EU Directives.

Directive Entered into Force Repeal Date Notes
R&TTE 1999/5/EC April 7, 1999 June 13, 2016 Products placed on the market prior to June 13, 2016 can continue under R&TTE until June 13, 2017
RED 2014/53/EU June 11, 2014 TBD Products placed on the market on June 13, 2016
or later must utilize RED

Table 1: R&TTE Directive and Radio Equipment Directive Transition

Market surveillance policy has been revised, to make it more comprehensive, and to place equal emphasis on both setting product requirements and market surveillance enforcement criteria. The market surveillance authorities are now not only required to check the conformity of a product according to its intended purpose, as defined by the manufacturer, but also under the conditions of use, which can be “reasonably foreseen,” meaning when such use could result from predictable human behavior, but with the assumption that the product will be used in accordance with the applicable laws. A very helpful EC publication covering these topics is the “Blue Guide on the Implementation of EU Product Rules” that is also available for free download from the EC website referenced at the end of this article.


Becoming RED

Now we will take a look at the transition from the R&TTE Directive 1999/5/EC to the new Radio Equipment Directive 2014/53/EU, and some of the specific changes this will bring. One of the first questions is When do we have to change? There is a transitional grandfathering period given in RED, which addresses this concern. Any products that are placed on the EU market in R&TTE conformity prior to June 13, 2016, can continue to be placed on the market under R&TTE until June 13, 2017. However, any products placed on the market on June 13, 2016 or later must be in conformity to RED, and all grandfathered products must conform to RED by June 13, 2017.

Development of RED started in 2007, and the EC sent the first proposals to the European Parliament in 2011. Following the normal process of requesting feedback from stakeholders, and using the provided input to revise the requirements, a compromise on the final text was achieved in January 2014. As mentioned, this is a New Legislative Framework directive, and it was published on May 22, 2014 in the Official Journal of the European Union. It entered into force on June 11, 2014, and all EU member states must amend their national regulations before June 13, 2016 to align with the RED criteria.

One of the first things you may notice about RED is that “Telecommunications Terminal” has been dropped from the title of the previous R&TTE Directive. This is because telecommunications terminal equipment, such as wired telephones and fax machines, has been removed from the scope of RED, and has been transferred to the scopes of the EMC Directive 2014/30/EU and Low Voltage Directive 2014/35/EU. RED will only apply to wireless and radio devices and equipment.

There is specific definition given for radio equipment in RED, which is “an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination, 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 radio determination.” This definition is important in understanding the extent of the types of radio equipment to be covered under the scope of this directive.

The scope of RED will cover radio transmission, including both radio communication and radio determination. The term Radio Determination is used to make clear that equipment such as RADAR, RFID, movement detection, and velocity measurement are within the scope of RED. Equipment which is not for radio communication or determination is not in the scope, such as equipment classified for Industrial, Scientific, & Medical (ISM), EN 55011, and CISPR 11.

Also in the scope will be radio reception equipment, including receive-only radio devices. One key change to the scope is the inclusion of broadcast receivers in RED, which were specifically excluded in R&TTE. Broadcast receivers had been in the scope of the EMC and Low Voltage Directives, but this will no longer be the case. Some items specifically excluded from the RED scope include aeronautical radio equipment, and custom evaluation kits intended for professional Research & Development, which are used in actual R&D facilities.

The frequency range of RED is expanded, up to 3 THz (3000 GHz), with no lower limit, meaning that zero Hertz to 9 kHz is now included in the scope. So any radio technologies that operate below 9 kHz now fall under this directive, and other standards bodies such as ETSI and ECO will have to catch up to this change in a standard update.

Another big change is that radio equipment assessed must be able to operate in at least one EU country; if not, it cannot obtain CE Mark. While under the R&TTE Directive, products could obtain Notified Body opinions and CE Marking for non-European markets, without being authorized for use in any EU country or CE-marking country, but this is not allowed under RED.

The requirements for animal safety have been clarified in RED. Although the R&TTE Directive did include safety considerations for animals, it wasn’t clear. RED specifies and clarifies the requirements for the protection of the health and safety of persons, domesticated animals, and property, including the objectives with respect to safety requirements set out in Directive 2006/95/EC (Low Voltage Directive), but with no voltage limit.

One of the main changes was to clearly identify and define all of the economic operators involved in the process of placing products onto the EU market, so clear roles, obligations, and responsibilities could be assigned, and the market surveillance agencies would be able to assign accountability when issues are found. The four key economic operators are identified as manufacturers, authorized representatives of the manufacturers, distributors, and importers. The manufacturers and importers have been called out as being the two operators that will be held the most accountable for any conformity issues found in the EU, and their expanded roles spelled out in RED reflect this. The chapter 2 definitions in the directive should be closely studied by all of the identified groups, as there will be much more scrutiny and market surveillance activities associated with the different parties, and it will be vital to clearly understand what is required for each operator.

Another new requirement is RED is the mandate to provide more contact information for the economic operators. EU Member States will require the economic operators to include both website addresses and physical location postal addresses, in order to facilitate better communications between the member states, market surveillance authorities, economic operators, and consumers. The equipment must show the product identification numbers and contact information for the responsible parties. A contact name and details must be supplied with each device, and also placed on the device, or in documentation if it is a small device. Importers must show similar information on the equipment or on the packaging; the supply chain must accept the legal responsibility for providing valid contact information.

The conformity of equipment is covered in chapter 3 of RED, with two types of procedures. Internal production controls are covered in detail in Annex II, and the EU-type examination procedures are specified in Annex III. Information that concerns the continued conformity of the equipment will be reviewed, checking that specific precautions that must be taken when the device is assembled, installed, maintained, or used are included and valid. Any equipment that does not meet the requirements for residential areas must be accompanied by a clear indication in the user instructions on the restriction of use to non-residential areas only, and where appropriate it must also be on the packaging.

The requirements and procedures for the notification of Conformity Assessment Bodies (CAB) is found in chapter 4. This includes the requirements and obligations of notifying authorities and notified bodies, including information on applications, changes, operations, appeals, coordination, and notification procedures. Also included is information on challenging the competence of notified bodies, and how to make an appeal against a decision made by a notified body.

Chapter 5 covers market surveillance, which is an area that will be subject to much more activity under the NLF scheme. The national market surveillance authority will act on any product that presents a risk at the national level, and under the referenced procedure they will notify all member states and the EC. The specific definition of risk, however, is left open, so this presents some ambiguity on when the authority might act.

For any formal non-compliance, such as an incorrect CE mark, or a product that is missing manufacturer or importer details, the EU member states will require the relevant economic operator to correct the non-compliance. If the issue is not corrected, the member state must take all appropriate measures to restrict or prohibit the product being made available on the market, or they should ensure that it is recalled or withdrawn from the market. The member states have the authority to set the rules on penalties that are applicable to any national law violations by the economic operators, and they can take all necessary measures to ensure enforcement, including criminal penalties for serious infractions.

The updated requirements for the CE Declaration of Conformity (DOC) are found in Annex IV. The product model name and identification numbers are required as before, but it must also include all of the expanded contact information, to support the traceability requirements. A photograph of the equipment can be included in the DOC, but it must be in color, and of high enough resolution to clearly identify the product. One new benefit is that all of the applicable directives and standards can be listed on one DOC for the product, although it may need to include multiple pages for all of the required listings for the relevant harmonized standards used, including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared. When it is applicable, the notified body that performed the type examination and issued the certificate should also be identified and listed. Also, the DOC must be translated into the language or languages required by the member states for which the apparatus is placed or made available on the market.

Universal charger requirements have been codified under RED. Presently, common or universal chargers are optional under industry memorandums of understanding, but it will be a requirement in RED for universal chargers for certain products, such as mobile phones, tablets, cameras, and music players. The intent is to reduce the environmental impacts of a multitude of chargers, and the inconvenience they present for consumers.

RED allows electronic labelling for certain appropriate types of equipment, such as devices with a built-in display screen. Other information may also be permitted electronically, such as the model and contact points. Devices requiring an initial charge could have a removable label for shipping.

Under RED there won’t be a requirement for EU member state notifications for non-harmonized Class 2 equipment, although this was required under the R&TTE Directive. In addition, the Class 2 Alert symbol (the circle with the exclamation mark) has also been removed from the requirements.

The CE Mark will no longer be required to be printed in the user manual. The R&TTE Directive had required the CE Mark in user manual, but RED removed this.

Figure 1: CE Mark for Non-Harmonized Class 2 Equipment with Alert Symbol

Figure 1: CE Mark for Non-Harmonized Class 2 Equipment with Alert Symbol


Where To Go From Here?

We’ve covered a lot of ground, but I’ve only provided a broad overview of the upcoming changes. You should start now to understand the impacts this will have for your organization, and start making your own transition plans and alerting your management of these upcoming requirements. The good news is you have at least a couple of years to get this all completed.

There is a wealth of information that can be found on the official European Commission website (ec.europa.eu), including EU compliance publications, such as free downloads of the EU Directives in PDF and HTML file formats, and Official Journal of the European Union documents. A very helpful EC publication is “Blue Guide on the Implementation of EU Product Rules” that is also available for free download. Two other official EU websites that are useful are the Official Journal of the EU website (www.eur-lex.europa.eu), and the official European Union website (www.europa.eu).


Internet Resources

The European Commission website
ec.europa.eu

The EU New Legislative Framework (NLF), European Commission webpage
ec.europa.eu/enterprise/policies/single-market-goods/documents/internal-market-for-products/new-legislative-framework/index_en.htm

The EU New Radio Equipment Directive (RED), European Commission webpage
ec.europa.eu/enterprise/sectors/rtte/radio-equipment-directive/index_en.htm

EU Eur-Lex, the Official Journal of the EU, website
www.eur-lex.europa.eu

EUROPA, the Official EU website
www.europa.eu

 

author maynard-markMark Maynard is the Director for Business Development and Marketing at SIEMIC, a global compliance testing and certification services firm with locations in the US, China, Taiwan, and South Korea. He is a Senior Member of the IEEE, and also on the Board of Directors for both the IEEE Product Safety Engineering Society and the Telecommunication Certification Body Council. Mark holds two degrees from Texas State University, a BS in Pure Mathematics, and a BAAS in Marketing and Business. Prior to SIEMIC, he worked for over 20 years at Dell, in international regulatory compliance and product certifications, with various compliance engineering roles including wireless, telecom, EMC/EMI, product safety, and design for the environment. He can be reached at mark.maynard@siemic.com.

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