Europe’s New EMC, Low Voltage and Radio Equipment Directives

Recast versions of the EU’s EMC and Low Voltage Directives are now in effect while the entirely new Radio Equipment Directive can also apply (it is being phased in). This article considers the requirements of each of the Directives, discussing similarities and differences between the laws.

Earlier this year, on 20 April, the requirements of the European Union’s (EU’s) recast Electromagnetic Compatibility (EMC) and Low Voltage Directives became effective, while a little later, on 13 June, those of the entirely new Radio Equipment Directive (RED) took effect (although a phase-in applies in this instance whereby radio equipment can continue to be placed on the market until the end of 12 June 2017 that complies with the Radio Telecommunications and Terminal Equipment (R&TTE) Directive). For businesses involved in the manufacture, export and sale of electrical and electronic equipment to EU Member States, these legislative changes are of note. While the so-called “essential requirements” of the EMC and Low Voltage Directives remain as before, there are administrative changes to be aware of, as well as obligations pertaining to different “economic operators” within supply chains.

Meanwhile, the RED supersedes the R&TTE Directive and affects a different range of products in the process. Although an entirely new Directive, the RED shares some pertinent similarities to the recast EMC and Low Voltage Directives with regards to economic operator obligations as well as equipment conformity and market surveillance/control of equipment provisions.

This article looks at what the Directives require from an industry perspective, considering similarities and differences between the three laws.

Overview of the New Directives

The Directives span close to 100 pages of legal text. There is then European Commission guidance to consider as well as guidance originating from EU Member State governments and national market surveillance authorities. How then to cut through such voluminous documentation and present the essence of each law?

One approach is “5W1H,” a technique that engineers involved with one or more of product design, approval, quality and/or reliability are likely to have at least some familiarity with (it is also used in Six Sigma). At its heart, it is the simple act of answering five questions that begin with the letter “w” and one question that begins with “h”. In other words, who, what, why, where, when and how? Table 1 presents answers to each of these questions as they relate to the three new Directives.

Table 1: 5W1H analysis for the new EMC, Low Voltage and Radio Equipment Directives

* Not all of these requirements will necessarily apply to each economic operator.

Having both introduced and summarized the content of each of the new Directives, the article now moves to discuss key points of similarity and difference from a practitioner standpoint.

Similarities

Context

The three new Directives share a number of similarities owing to the fact that they are all aligned to the EU’s New Legislative Framework (NLF). Also known as the “Goods Package,” the NLF comprises two EU Regulations – 764/2008 and 765/2008 – and one Decision, 768/2008/EC. The NLF was conceived in the mid-to-late 2000s to update the New Approach to technical harmonization and standardization that had existed since the 1980s.

Many of the defining elements of the New Approach carry forward in the NLF: for instance, that product laws have “essential requirements” with the technical detail required for implementation worked out via standardization activities and leading to “harmonized standards” being adopted and referenced in the Official Journal of the European Union. Not only this, but a manufacturer can assume a “presumption of conformity” when designing and making his equipment in accordance with one or more relevant harmonized standards while he must compile technical documentation as evidence of compliance, prepare and sign a Declaration of Conformity, and affix the CE marking to his equipment.

All of these now long-standing hallmarks of EU technical product regulation also apply in the case of the NLF. However, the NLF adds further elements. One such element is the usage of the term “economic operators” and the setting of different obligations depending on what businesses do within supply chains (elaborated upon below). A further element occurs in the strengthening of conformity assessment, specifically with regards to stronger and clearer rules pertaining to the notification of conformity assessment bodies. Still further is a strengthening in market surveillance procedures, something that includes detail on what national authorities are to do in the case of equipment being found to be non-compliant.

With this context in mind what then are the similarities? For those involved in handling equipment (whether this entails designing, making, selling and/or distributing), the following are noteworthy and will be discussed in turn: economic operator obligations, presumption of conformity, conformity assessment, technical documentation, Declaration of Conformity, and the CE marking. All of the Directives refer to these in a near-identical manner. This does not mean that they are always exactly the same though; indeed, there are some relevant differences to point out on occasion. However, the new Directives are broadly the same on these points. Unsurprisingly, it is their scope of application and, moreover, their product-specific requirements that set them apart from one another.

Economic Operator Obligations

The NLF refers to “economic operators,” i.e. manufacturers, authorized representatives, importers and distributors. The NLF defines each of these in Regulation 765/2008 as follows:

• A “manufacturer” means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets the product under his name or trademark.
• An “authorized representative” means any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regards to the latter’s obligations under the relevant Community legislation.
• An “importer” means any natural or legal person established within the Community who places a product from a third country on the Community market.
• A “distributor” means any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market.

The new Directives all incorporate these references and definitions, although “the product” is either equipment liable to generate/be affected by electromagnetic disturbance, electrical equipment or radio equipment depending on the law in question. Each of the new Directives also set obligations for the four economic operators, which are summarized in Table 2.

Table 2 is an adaptation of an existing table found on the UK Government Department for Business website, and it summarizes the economic operator obligations from the EU Restriction of Hazardous Substances (RoHS) Directive. Since the RoHS Directive is also aligned to the NLF and has the same economic operator obligations written into it as the new Directives, it made sense to adapt the UK Government summary since this already presents the information in both a clear and succinct manner.

Table 2: The obligations of the four types of economic operator found in the new Directives

Presumption of Conformity/Use of Standards

A presumption of conformity is written into each of the new Directives. This states that equipment falling within the scope of a Directive “…which is in conformity with harmonized standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity [with the Directive’s essential requirements].” Product testing is usually required for equipment to be considered in conformity with harmonized standards. Manufacturers (or other economic operators) may have the capability to do such testing in-house, but more often they are likely to direct this to test laboratories to perform on their behalf.

While all three of the new Directives provide a presumption of conformity when equipment is in conformity with harmonized standards, the recast Low Voltage Directive differs to the recast EMC Directive and RED by also referencing international and national standards. This particular referencing appears to be something of an acknowledgement that harmonized standards can take time to draw up, and might not always be in place. International – or else national – standards may then constitute suitable alternatives, and can be used for conformity assessment and referred to in a Low Voltage Directive Declaration of Conformity.

Conformity Assessment

All of the three new Directives stipulate that conformity assessment – the process of demonstrating whether specified requirements relating to a product have been fulfilled – is “solely the obligation of the manufacturer.” This is on account of manufacturers having “detailed knowledge of design and production processes” thereby making them “best placed to carry out the conformity assessment.”

While the new Directives all have this in common, they differ inasmuch as they offer different conformity assessment routes – or “procedures” – to manufacturers. This is detailed in the “How?” row found in Table 1. Internal production control is the one and only choice of procedure under the recast Low Voltage Directive, while the recast EMC Directive offers this together with “EU type examination” as a separate possibility, and the RED offers a choice between internal production control, “EU type examination” or else “conformity based on full quality assurance.” (That is, unless the radio equipment manufacturer does not fully utilize harmonized standards to show conformity, then he is limited to EU type examination or full quality assurance – i.e. Modules B, C or H.)

It is worth elaborating further on these procedures, as follows:

• Internal production control (Module A of Annex II, Decision 768/2008/EC). This relates to a manufacturer’s own controls with the manufacturer then declaring equipment compliance on the basis of technical documentation compiled, checks undertaken in manufacturing and by ensuring relevant markings are affixed to equipment (e.g., the CE marking, but also anything required by relevant harmonized standards applied such as input/output ratings and insulation class). A Declaration of Conformity is also to be written. One important point to note with respect to internal production control is that, for manufacturers that wish to employ harmonized standards but do not necessarily have equipment/expertise to test against them, it is likely to extend to third party product testing/certification. This can make the title “internal production control” a little misleading.
• EC-type examination (Module B of Annex II, Decision 768/2008/EC). This procedure differs from internal production control since conformity assessment will always involve a third party – a “notified body” – to examine equipment technical design, and to verify and attest that this design meets relevant legal requirements.
• Conformity to type based on internal production control (Module C of Annex II, Decision 768/2008/EC). This conformity assessment procedure is, in effect, a merger of Modules A and B described in the preceding bullets.
• Conformity based on full quality assurance (Module H of Annex II, Decision 768/2008/EC). This conformity assessment procedure combines elements of internal production control (specifically compilation of technical documentation) with examination, by a notified body, of a manufacturer’s quality system.

Further detail can be found in Annex II of Decision 768/2008/EC where each of the above-mentioned Modules are introduced and defined together with a number of others.

Technical Documentation

The compilation and retention of technical documentation was a feature of the New Approach to technical harmonization and standardization and is something that carries forward into the NLF (and all product laws that are aligned to the NLF, such as the three new Directives) largely unchanged. As detailed previously, manufacturers must draw up technical documentation. Each of the three new Directives state that such documentation is to consist of:

• A general description of the equipment [whether electrical equipment or radio equipment];
• Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
• Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the equipment;
• A list of harmonized standards applied in full or in part [or a list of international or national standards in the case of the recast Low Voltage Directive];
• Results of design calculations made, examinations carried out, etc.; and
• Test reports.

This is all relatively straightforward. However, the technical documentation required in NLF-aligned laws must also “make it possible to assess the equipment’s conformity with applicable requirements of [the] Directive and shall include an adequate analysis and assessment of the risk(s).” As just a note of guidance on this, the concept of risk entails consideration of both hazard and the likelihood of occurrence (perhaps through assessment of exposure). In other words, it is not just everything that could go wrong, but the likelihood of each scenario occurring and the potential severity of each scenario. Any assessment should account for this on an informed, and reasoned, basis.

Declaration of Conformity

Just as technical documentation was a feature of the NLF, so too was the writing of a Declaration of Conformity. However, there is now a specified “model structure” for Declarations of Conformity under the NLF. This is reproduced in all three of the new Directives and includes:

• The title, “EU Declaration of Conformity;”
• The assignment of a number to the Declaration [this is optional];
• The inclusion of the statement: “This declaration has been issued under the sole responsibility of the manufacturer;”
• The inclusion of the statement: “The object of the declaration is in conformity with relevant Union harmonization legislation;”
• A means to suitably identify the equipment, sufficient to allow equipment traceability [e.g., a color image of the equipment could be employed];
• Referencing of the applicable Directive number (e.g., 2014/30/EU in the case of the recast EMC Directive);
• Referencing of relevant harmonized standards used, or else referencing of other specifications against which equipment conformity is declared;
• Identification of a signatory with respect to the “signed for and on behalf of” requirement.

Note that this model structure does not require the last two digits of the year in which the CE marking was affixed to be stated in the Declaration of Conformity. This was previously a requirement but is no longer the case now. In addition, the NLF requires that manufacturers issue one Declaration of Conformity for each item of equipment placed on the market. This Declaration may list all applicable Directives and standards with which the equipment complies.

CE Marking

Each of the new Directives requires the CE marking to be affixed to in-scope equipment. Each Directive also makes reference to the general principles of CE marking set out in Article 30 of Regulation 765/2008. These principles include that: 1) the CE marking is to be affixed only by the manufacturer or his authorized representative; 2) this affixing indicates that the manufacturer takes responsibility for the conformity of the product with all applicable requirements set out in relevant legislation; and 3) the CE marking be the only marking to attest legal conformity.

Interestingly, the RED also makes specific provision for the CE marking to be of reduced height (less than 5mm) on small-sized equipment. This is “on account of the nature of radio equipment” with the proviso that the CE marking remains “visible and legible.” This exemption is not found in either of the recast Low Voltage or EMC Directives.

Differences

As mentioned previously, the three new Directives vary in their scope of application as well as product-specific requirements. Key points of difference span equipment definitions (“radio equipment” is different from the “equipment” falling in scope of the EMC Directive, which is also different from the “electrical equipment” in scope of the Low Voltage Directive), the exclusions that apply, and essential requirements. The “Who?” and “What?” rows in Table 1 elaborate on these points while Table 3 provides further detail with respect to essential requirements.

Table 3: The essential requirements of the three new Directives

Concluding Remarks

There are a number of similarities as well as differences between the three new Directives. Perhaps chief among the similarities are the inclusion of the same economic operator obligations within the legal texts, particularly as these obligations span the likes of compiling technical documentation, writing the Declaration of Conformity, and affixing the CE marking to equipment. Differences arise when it comes to what equipment falls in scope, exclusions and essential requirements – although the RED includes the essential requirements of the recast EMC and Low Voltage Directives. In order to manage compliance as effectively and efficiently as possible, practitioners should be wise to the similarities and differences.

Moreover, they should be able to relate the Directives and the economic operator obligations they lay down to their business models. This includes knowing when a business is functioning as more than one type of economic operator – a situation that could arise if, say, a business is involved in making equipment for others under contract on the one hand, while also making, distributing and selling equipment in the EU under its own name and trademark on the other hand. These considerations are central to what legal obligations apply and what steps a business then needs to take to meet its obligations.

Dr. Alex Martin is Senior Regulatory Consultant at Edif ERA (www.edifera.com). Alex provides advice and compliance support on various regulations affecting electro-technical products, from EMCD, LVD and RED through to environmental laws like RoHS, REACH and WEEE. Alex is contactable on alex.martin@edifera.com.