Harmonised standards for wireless devices

Considering the wide-ranging presence of radio signals and the increasingly diffusion of devices connecting through wireless, mobile networks and GPS, the European Commission published on 22 May 2014 the Radio Equipment Directive (2014/53/EU), which aims at regulating the placing on the market of radio-electric equipment. This new directive, also known as the RED, entered into force in 13 June 2016 and repealed the previous Radio and Telecommunications Terminal Equipment (R&TTE) directive (1999/5/EC).

Manufacturers have to ensure that their equipment has been designed and manufactured according to the essential requirements under the RED. The essential requirements as laid out in the Directive require that radio-electric equipment shall be constructed to ensure protection of health and safety, adequate level of electromagnetic compatibility and the efficient use of radio spectrum to avoid harmful interference. Only the equipment which conforms to the harmonised standards referenced in the Official Journal of the European Union (OJEU) is presumed to conform to the essential requirements.


Harmonised standards under the RED

Harmonised standards under the RED are developed by the European Telecommunications Standards Institute (ETSI) and European Committee for Electrotechnical Standardization (CENELEC), on the basis of standardisation requests issued by the European Commission.

There is no obligation for manufacturers to apply harmonised standards under the RED. However, referring to harmonised standards has the advantage of giving “presumption of conformity” with the corresponding essential requirements that a given manufacturer aims to cover. When deciding not to follow a harmonised standard or to follow it only partly, manufacturers have the obligation to prove that their products are in conformity with the essential requirements by other means., i.e. turning to notified bodies.

When the RED was published in May 2014 together with the dates of its application, it was clear that the short deadline would have not been sufficient to issue the supporting harmonised standards. Ideally, all harmonised standards should have been available by 13 June 2016. In practice, this result was not achieved and manufacturers were given a further year, until 12 June 2017, to comply with the new directive.


Status of availability of harmonised standards and related impacts

Most of the 170 harmonised standards for the RED have been published by ETSI and CENELEC and are referred to in the Official EU Journal. However, a smaller number of standards is still not available.

To date, following the last round of assessment of candidate harmonised standards, 114 out of 133 standards delivered by ETSI were published in the EU Official Journal (“OJEU”). 20 additional harmonised standards from the old R&TTE directive have been added to the list for a total of 134 “unique” harmonised standards. This is far from the number of standards (170) to be issued for the full implementation of the RED. The publication of the remaining standards may take place on a later stage, maybe even next year.

Despite the Commission has made specific arrangements to make sure that as many harmonised standards as possible are published in the OJEU after they are delivered by the standardisation organisations, manufacturers suffer the current situation that forces them to obtain conformity certification from notified bodies in absence of harmonised standards. Referring to notified bodies for certification purposes has a significant impact on costs that constitute a remarkable barrier for SMEs that wish to sell their products.

The European commission underlines in its FAQs that transition to the RED was handled with all the necessary care to help the industry to prepare for the new rules. In this document, the Commission points out that the preparation of harmonised standards is the only part of the implementation of the RED that was delegated to standardisation organisations, which are composed of industry experts and other stakeholders. With this regard, a low level of involvement of experts has been registered in standardisation activities in support of the RED.

To overcome these issues, the Commission has made specific arrangements to allow the prompt citation of harmonised standards in the OJEU once these are issued by standardisation organisations. As of 2016, the Commission started publishing the list of harmonised standards in the OJEU on a monthly basis. This is an unprecedented exercise (harmonised standards for other Directives or Regulations are usually published every third month) and industry, in absence of the possibility to extend the transition period to comply with the RED, hopes this will be enough to make all the relevant standards available without further delay.