Update Internet of Things (IoT)

Specialist for healthcare compliance market measures

Conformity assessment in the area of application of the RED Directive

Important act of law for IoT, Industry 4.0, digitalisation and connectivity

Since as long ago as 13 June 2016, the regulatory requirements for radio equipment in accordance with the Radio Equipment Directive 2014/53/EU (RED) have been applicable. The list of harmonised standards, however, was not complete when the statutory transition period expired on 12 June 2017, or rather, it was not possible to publish it in time in the Official Journal of the European Union. One of the reasons for this was major technical deficiencies, which required the respective standards to be revised. Other standards were simply not sent to the Commission for publication in time before expiry of the transition period. 

Manufacturers who had placed their radio equipment on the market by 12 June 2017 are not affected by these problems, as their products are allowed to stay on the market if and to the extent that they comply with the legal requirements of the R&TTE Directive 1999/5/EC. Manufacturers who wish(ed) to launch their product after 12 June 2017, on the other hand, are confronted by the problem of not being able to place it on the European internal market without further ado or without risk.

As we reported in the July issue, the German market is an exception, because in Germany the new Radio Equipment Act (FuAG) came into force on 4 July 2017. The FuAG enables the manufacturers of radio equipment also to launch it after 12 June 2017 as long as it complies with the harmonised standards which applied previously under Directive 1999/5/EC

Until such time as all the harmonised standards have been published in full, all other manufacturers can assess and declare the conformity of their products to the basic requirements of the RED applying other (technical) specifications, because it is not mandatory to apply harmonised standards in the conformity assessment procedure. Only if it a question of assessing and providing evidence of compatibility with the basic requirements of Article 2 (2) and (3) of the RED must a notified body be involved in the assessment process. 

The list of notified bodies can be viewed on the Commission website. Manufacturers can as a matter of basic principle approach any notified body in the European Economic Area which has capacities available. The notified bodies do not conduct tests or inspections themselves, but analyse the information and data provided by the manufacturer.

The outlook

As long as not all the (new) harmonised standards relating to the RED have been published in the Official Journal of the EU, manufacturers who wish to place their equipment on the market in Germany can in their conformity assessment procedure have recourse to the list of standards published previously under the preceding Directive 1999/5/EC. As for placing their equipment on other European markets, manufacturers of radio equipment can in the current legal circumstances only have full confidence in the conformity of their products if they involve a notified body in the conformity assessment procedure. 

It is conceivable that this process will work fast and without complication, since the notified bodies do not conduct surveys of their own. However, the additional time and cost factor should definitely be considered in manufacturers’ calculations until such time as all the harmonised standards relating to the RED have been published. 

[August 21st, 2017]