New European Union Directives and Their Impact on Notified Bodies

The European Union (EU) released revised versions of three important directives in 2014, namely the Electromagnetic Compatibility Directive (EMCD), the Radio Equipment Directive (RED) and the Low Voltage Directive (LVD). Each of these three revised directives will be discussed and compared/contrasted to their earlier versions. We’ll then analyze the impact of these directives as to their influence on strengthening EU Notified Bodies. The article concludes with a summary of the directives and Notified Bodies.

Table 1: EMC, Radio, and Low-Voltage Directives – A Historical Review

A Brief Review of the History of the Three Key European Directives

The European Commission recently released a reference document title “Application of Directives 2014/53/EU, 2014/35/EU, and 2014/30/EU.” That reference document provides guidance on the dates of applicability and the transitional periods for the three 2014 directives.

EMC Directive

The latest EMCD (2014/30/EU) was released on 26 February 2014 and published in the Official Journal of the European Union on 29 March 2014. It addresses “the harmonization of the laws of the Member States relating to electromagnetic compatibility.” The 2014 EMCD is a “recast” of the 2004 EMCD (2004/108/EC). It also reflects a 2008 law-change by the European Parliament that modified the requirements for accreditation and market surveillance relating to the marketing of products. The EMCD also states that “provisions of national law ensuring protection against electromagnetic disturbance need to be harmonized in order to guarantee the free movement of electrical and electronic apparatus without lowering justified levels of protection in the Member States.”

The equipment covered by the updated EMCD includes separate provisions for both apparatus and fixed installations. The Directive makes clear that “economic operators” (defined as “the manufacturer, the authorized representative, the importer and the distributor”) should be responsible for the compliance of apparatus with the Directive. For example, all economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market apparatus which are in conformity with the EMCD.

An important concept highlighted by the EMCD is “ensuring traceability.” Traceability must be assured throughout the whole supply chain to make market surveillance simpler and more efficient. As part of this traceability, Member States should encourage economic operators to include a website address in addition to their postal address.

Clause 38 of the preface to the EMCD highlights the fact that:

“Experience has shown that the criteria set out in Directive 2004/108/EC that conformity assessment bodies have to fulfill to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union.”

This concern has led to stricter requirements for Notified Bodies, which will be discussed more fully in the last part of this article.

Radio Equipment Directive (RED)

Directive 2014/53/EU of the European Parliament and of the Council was released on 16 April 2014 and was published in the Official Journal on 22 May 2014. It harmonizes the laws of EU Member States relating to the making available on the market of radio equipment, and repeals Directive 1999/5/EC.

Directive 1999/5/EC had been substantially amended several times and additional amendments were pending. Therefore, the EU Commission decided it should be replaced in the interests of clarity. The 1999 Directive had the unwieldy title of “Radio Equipment and Telecommunications Terminal Equipment” which was abbreviated as “R&TTE.” This acronym has been replaced with the much simpler “RED” (for “Radio Equipment Directive”).

An important change in the RED is covered in Clause 4 of the Directive’s Preface, where it says:

“The essential requirements laid down in Directive 1999/5/EC which are relevant to fixed-line terminal equipment, i.e. to ensure the protection of health and safety of persons and of domestic animals and the protection of property and an adequate level of electromagnetic compatibility, are appropriately covered by Directive 2014/35/EU of the European Parliament and of the Council and Directive 2014/30/EU of the European Parliament and of the Council. This directive should therefore not apply to fixed-line terminal equipment.”

Clause 10 of the RED Preface gets to the heart
of the issue:

“In order to ensure that radio equipment uses the radio spectrum effectively and supports the efficient use of radio-spectrum, radio equipment should be constructed so that, in the case of a transmitter, when the transmitter is properly installed, maintained,
and used for its intended purpose it generates radio waves emissions that do not create  harmful interference, while unwanted radio waves emissions generated by the transmitter (e.g., in adjacent channels) with a potential negative impact on the goals of radio spectrum policy should be limited to such a level  according to the state of the art, harmful interference is avoided, and, in the case of a receiver it has level of performance that allows it to operate as intended and protect it against the risk of harmful interference in particular from shared or adjacent channels, and, in so doing, supports improvement in the efficient use of shared or adjacent channels.”

Also, radio equipment which complies with the relevant essential requirements should be allowed to circulate freely, such equipment should be allowed to be put into service and used for its intended purpose where applicable in accordance with rules on authorizations for the use of radio spectrum and the provision of the service concerned.

Clause 48 of the preface to RED says that “certain conformity assessment procedure set out in this Directive require the intervention of conformity assessment bodies which are notified by the Member States to the Commission.”

Furthermore, Clause 49 says:

“Experience has shown that the criteria set out in Directive 1999/5/EC that conformity assessment bodies have to fulfill to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under condition of a fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.”

Also, Clause 52 concludes:

“The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No. 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.”

The above Clauses are similar to what is found in the EMCD and they are what is driving a renewed emphasis on the competency of Notified Bodies, which will be covered in the last section of this article.

Low Voltage Directive

The third new version of a directive affecting electronic products accepted into the EU market is the Low Voltage Directive (LVD). The LVD was released on 26 February 2014 (the same date as the EMCD ) as Directive 2014/35/EU, and its official title is: “the harmonization of the laws of the member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits.” The Directive was published in the Official Journal on 29 March 2014.

A number of amendments had been made to the existing LVD (2006/95/EC) of 12 December 2006 on the harmonization of the laws of Member States relating to electrical equipment designed for use within voltage limits. Therefore in the interests of clarity, the EU Commission determined that the LVD should be recast.

The new LVD states:

“The purpose of this Directive is to ensure that electrical equipment on the market fulfils the requirements providing for a high level of protection of health and safety of persons, and of domestic animals and property, while guaranteeing the functioning of the internal market.”

The new LVD also notes that economic operators should be responsible for the compliance of electrical equipment with the LVD in relation to their respective roles in the supply chain so as to ensure a high level of protection of public interests, such as health and safety of persons, of domestic animals and property, and to guarantee fair competition within the EU.

The LVD goes on to say in Clause 9 of the Preface:

“The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer. There is no conformity assessment procedure in this Directive which requires the intervention of a notified body.”

The new LVD is limited to the expression of the safety objectives. Furthermore, electrical equipment should be considered as non-compliant with the safety conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behavior.

Notified Bodies

Notified Bodies are defined as “Conformity Assessment Bodies that have been notified to the European Commission and the European Member States that they are authorized to carry out third-party conformity assessment tasks for specific European Directives.” Notifying Authorities are designated by Member States and they “shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies compliance with appropriate sections of selected Directives.”

Both the EMCD and the RED allow and encourage the use of Notified Bodies. The LVD has no conformity assessment procedure requiring the use of a Notified Body.

A Notified Body must meet a number of requirements to be acceptable to a Notified Authority. For example, it must be “established under national law of a Member State and have legal personality.” Also, it “shall be a third-party body independent of the organization or the apparatus it assesses.”

All Notified Bodies are required to be re-notified if they wish to continue serving as Notified Bodies under the revised EMCD and the new RED. The process of re-notifying Notified Bodies in the U.S. is being administered by the National Institute of Standards and Technology (NIST) in the U. S. Department of Commerce. The specific office in NIST that is heading this effort is the Telecom Mutual Recognition Agreement (MRA) Program Office which is part of NIST’s Standards Coordination Office.

The EU has been updating its documentation to aid the transition to implementing the new or revised directives introduced in 2014. One of these publications is “The ‘Blue Guide’ on the Implementation of EU Product Rules – 2014.” Its Preface says:

“The Guide to the implementation of directives based on the New Approach and the Global Approach (the ‘Blue Guide’) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework.

“Much of the 2000 edition of the ‘Blue Guide’ is still valid but it requires updating to cover new developments and to ensure the broadest possible common understanding on implementation of the New Legislative Framework (NLF) for the marketing of products. It is also necessary to take account of the changes introduced by the Lisbon Treaty (in force since 1st December 2009) with regard to the legal references and terminology applicable to EU-related documents, procedures, etc.

“This new version of the Guide will therefore build on the past edition, but include new chapters, for example on the obligations of economic operators or accreditation, or completely revised chapters such as those on standardization or market surveillance. The guide has also been given a new title reflecting the fact that the New Legislative Framework is likely to be used, at least in part, by all types of Union harmonization legislation and not only by the so-called ‘New Approach’ directives.”

The Guide is intended to aid a better understanding of EU product rules and to their more uniform and coherent application across different sectors and throughout the single market. It is intended solely as a guidance document.

A second complementary document to the “Blue Guide” is the “European co-operation for Accreditation (EA) Document on Accreditation for Notification Purposes.” It is referenced as “EA-2/176 M:2014.” This document presents the policy agreed by EA members for accreditation of Conformity Assessment Bodies for notification purposes. It is a mandatory document except for Annex B which shall be used on an informative basis. Annex B is titled: “Criteria laid down in the harmonized standards used as a basis for accreditation that deal with the requirements for notified bodes laid down in Decision (EC) 78/2008 of the European Parliament and of the Council on a common framework for the marketing of products.”

A third document from the EU relative to accreditation and notification is the “RED Notified Body Accreditation/Notification Assessment Guide Document” (V1.0c) which is dated December 2014. It was issued through the Radio and Telecom Terminal Equipment Compliance Association (RTTE CA) and is also known as the “RED NB Assessment Guide.” It is written in a checklist format. The intent of the checklist is to improve the uniformity of the assessments of Notified Bodies throughout Europe and MRA countries. It is recommended that Accreditation Bodies use it.

The RED NB Assessment Guide states that “a Notified Body does not have to assess equipment that has been tested to harmonized standards. However, they must assess against Article 3.2 where harmonized standards have not been followed in full.” Article 3.2 of the RED says that “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.”

The RED NB Assessment Guide also points out that “the Radio Equipment Directive Article 3.1 (a) – Low Voltage Directive and Article 3.1 (b) – EMC Directive do not require a Notified Body to be involved where the equipment has not followed the harmonized standards.”

The EU Commission and other relevant stakeholders are still working on development of additional guidance documents, including the Commission EMCD Guide and the Commission RED guide. Additional checklists are being developed by European experts and by NIST for both the EMCD and RED.

Summary

The directives released by the EU in 2014 encompassing EMC, product safety and radio regulations have been thoroughly updated and modernized, and will affect many electronic products imported into Europe.

In addition, two of the three directives (the EMCD and RED) are driving major changes in the process for qualifying Notified Bodies in Europe and Notified Bodies outside of Europe that are handled through Mutual Recognition Agreements. Formal accreditation of the Notified Bodies is now the preferred route for demonstrating Notified Body competence. In the U.S., organizations seeking Notified Body status should contact the NIST Telecom MRA Program Office to obtain the full list of requirements.

Daniel D. Hoolihan is the founder and principal of Hoolihan EMC Consulting. He serves as chair of the ANSI-ASC C63 Committee on EMC. He is also a past-president of the IEEE’s EMC Society, and a current member of the Society’s Board of Directors. Hoolihan is also an assessor for the NIST NVLAP EMC and Telecom Laboratory Accreditation program. He can be reached at danhoolihanemc@aol.com, or at 651-213-0966.