Harmonised standards give a presumption of compliance (also called "presumption of conformity") with the essential requirements of the directive. The significance of this is that if there is evidence that the equipment complies with the appropriate harmonised standard(s), then in case of dispute it falls to the authorities to demonstrate that the essential requirements are not met. On the other hand, if other means of compliance are used, including a notified body opinion, the obligation rests always with the manufacturer (or authorised representative) to demonstrate to the authorities that essential requirements are met. In other words, full compliance with a harmonised standard shifts the burden of proof of compliance (or not) with the essential requirements between the manufacturer and the authorities.

The most recent list of standards harmonised specifically for the purposes of the R&TTE Directive is set out in Commission Communication 2008/C 136/01 of 3 June 2008. A note to this publication indicates that "In addition standards published under Directives 2006/95/EC, 2004/108/EC, 90/385/EEC and 93/42/EEC may be used to demonstrate compliance with Articles 3.1.a and 3.1.b of Directive 1999/5/EC." The lists for these other Directives can be found on the "New Approach" pages of the Enterprise & Industry website.

• What makes a harmonised standard?
• When does the presumption of compliance apply?
• Which harmonised standards apply?
• What about subsequent amendments to the standard?
• What about harmonised standards and amendments not listed in the OJ?
• Where can I obtain copies of harmonised standards?

[Note: This answers below are specific to the R&TTE Directive and should not be interpreted as generally applicable to all New Approach directives. The detail varies from directive to directive.]

What makes a harmonised standard?

Under the R&TTE Directive, a harmonised standard must be prepared by a recognised standards body under a specific mandate issued by the European Commission. In practice, CENELEC and ETSI are the only bodies to have prepared such harmonised standards to date. This does not mean that all CENELEC and ETSI standards are harmonised standards. The "Foreword" to a standard will usually indicate whether it has been prepared as a candidate harmonised standard.

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When does the presumption of compliance apply?

The presumption of compliance does not apply immediately a harmonised standard is published by the standards organisation. Its title must first be published in the Official Journal of the European Communities with reference to its application under one or other of the Articles of the R&TTE Directive setting out the essential requirements. The publication will also include information about the cessation of the presumption of compliance of any relevant earlier standards.

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Which harmonised standards apply?

Just any harmonised standard will not do! In order to qualify for possible presumption of compliance, the equipment must be within the scope of the standard taking full account of the equipment's intended use (particularly the radio spectrum allocation in the case of Article 3.2 essential requirements). Even so, if equipment has potential for non-compliance with essential requirements in ways that are clearly not addressed in a harmonised standard then the presumption of compliance will not be complete. This situation is most likely to arise (but is not necessarily restricted to) situations where a generic standard is applied, for example where the nature of the equipment concerned has potential for emissions beyond the range envisaged in the generic standard or where a particular spectrum allocation (either through a national interface regulation or and Equipment Class 1 sub-class definition) conflicts with the requirements of the standard. In some situations, it will be necessary to apply more than one harmonised standard to gain a presumption of compliance even with just one of the essential requirements – for example Article 3.1a presumption of compliance may require the application of a harmonised electrical safety standard and a harmonised standard concerning radio frequency (EMF) exposure. In a similar way, it may be appropriate to apply only a part of a harmonised standard to gain a presumption of compliance with the phenomenon addressed. It is best to approach this by performing a risk assessment identifying all the issues relating to a particular essential requirement and then matching each issue or group of issues with a particular harmonised standard. In many cases, there will be one harmonised standard for Article 3.1(a), another for Article 3.1(b) and, in the case of radio equipment, a third for Article 3.2 but it is not always so simple! The risk assessment should be included in the technical documentation required by Annex II of the Directive.

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What about subsequent amendments to the standard?

Amendments to a harmonised standard are not in themselves of immediate relevance to the presumption of compliance. The important issue is the information concerning dates of withdrawal of the presumption of compliance of the unamended standard when notice of the amendment is published in the Official Journal of the European Communities. Usually, an appropriate period of overlap between the two versions of the standard will be allowed. This gives time for any testing required to validate compliance and for updating of the declaration of conformity or other documentation which may be required. If the declaration of conformity is explicit about the version of the harmonised standard applied (and the recommendation is that it should) then it must be updated by the time the date of withdrawal of the presumption of compliance arrives.

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What about harmonised standards and amendments not listed in the Official Journal?

It can sometimes take several months for the reference to a harmonised standard or an amendment to be published in the Official Journal of the European Communities. In the meantime, the presumption of compliance is not available but if it is important for other reasons to apply the standard or amendment in that period it is possible to secure a notified body opinion based on its use. This can be particularly important in the case of a new harmonised standard where no earlier version is being superseded. In general, notified bodies cannot be expected to give positive opinions on equipment that does not comply with harmonised standards even in this period.

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Where can I obtain copies of harmonised standards?

The responsible standards body is identified in the list of harmonised standards published in the Official Journal of the European Communities.
CENELEC standards can be purchased from one of their member organisations (the European national standards bodies). Several of them offer download services but prices vary and the best deals are sometimes available only by taking out a subscription. English texts can sometimes be bought more cheaply from countries where English is not the native tongue. (Denmark is sometimes recommended but do compare on a case-by-case basis.)
ETSI standards are generally available for download free-of-charge subject to certain usage restrictions. Use the search engine in the ETSI Public Downloads Area to find the standards you want – remember to check the "all versions" box if you are looking for a version that is not current.

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