Europe
In 1999 the EU liberalized the internal market for radio equipment by implementing the Radio and Telecommunication Terminal Equipment (R&TTE) Directive. To further improve the internal market for goods and strengthen the conditions for placing a wide range of products on the market, the European Union adopted the New Legislation Framework in 2008. With this new framework the EU boosts the quality of conformity assessment and improves the market surveillance. Under this new legislation framework the EU also implements the Electromagnetic Compatibility – Directive 2014/30/EU, the Low Voltage – Directive 2014/35/EU and the Radio equipment – Directive 2014/53/EU also known as RED.
We start with the definition of radio equipment as defined in the Radio equipment directive (RED) Article 2.1(1) as an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radio determination. We want to point out that with this definition radio receivers are explicitly covered by the RED.
To further specify the scope we want to mention that radio equipment installed in vehicles such as cars, caravans, trains, etc has to comply with the RED, so there are some exemptions not discussed here, and RFID tags are also covered.
Responsible Party
The union harmonisation legislation defines four different responsible parties as there are the manufacturer, the authorised representative, the importer and the distributor and defines them as ‘economic operators’. Under those economic operators the main responsibility is put on the manufacturer and some of his responsibilities are following below.
The manufacturer has to carry out the conformity assessment procedure and has to ensure that the equipment can operate in at least one member state of the European union. He is responsible for the compilation of the technical documentation and the issuance of a Declaration of Conformity (DoC) as well as the correct labelling of the product. There may also be the need for carrying out sample testing of the radio equipment made available on the market.
By a written mandate, the manufacturer may appoint an authorised representative to carry out some of his responsibilities on his behalf. This mandate shall at least include the obligation to keep the Declaration of Conformity (DoC) and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the radio equipment has been placed on the market. All of the other duties mentioned above may be transferred as well.
The importer of the radio equipment shall ensure that he is only placing compliant equipment on the market and as such that the manufacturer has followed correctly his obligations resulting form the Radio Equipment Directive (RED).
And finally the distributor shall act in due care of the Radio Equipment Directive (RED) when making radio equipment available on the market which includes but is not limited to ensuring that the product is bearing the correct labelling and accompanied by complete instructions and safety information. He shall ensure that the manufacturer has followed his obligations in correct manner. Essential requirements
In accordance with the Radio Equipment Directive (RED) any radio equipment shall be constructed in a manner as to ensure the protection of health and safety of persons and domestic animals, safeguard the level of electromagnetic compatibility as set out in the EMC directive and finally ensure the effective use of radio spectrum in order to avoid harmful interference.
Labelling
The Radio Equipment Directive (RED) obliges the manufacturer to affix the CE marking to the equipment when placing a product on the market. This marking shall have a minimum height of 5 mm and shall also be affixed visibly and legibly to the packaging. If the nature of the radio equipment does not allow a marking of at least 5 mm, the manufacturer may affix a CE marking that is smaller than 5 mm to the product as long as it remains visible and legible. If it is not possible to affix a CE marking on the product, the manufacturer may affix it visibly and legibly only to the packaging.
In case a notified body was involved in the conformity assessment procedure the CE marking has to be followed by the identification number of the notified body in the same height as the CE marking.
Notified Body
A Notified Body (NB) is a third party designated by the competent authority of the EU member state, EEA member state or any other country that has concluded a Mutual Recognition Agreement (MRA) with the European Union to perform the conformity assessment tasks described in the Radio Equipment Directive (RED).
A list of appointed Notified Bodies is available on the European Commissions website including address details of each Notified Body as well as the tasks for which they have been notified.
If the manufacturer has not applied or not fully applied the relevant parts of the applicable harmonised standard in order to cover Article 3.2 and 3.3 of the Radio Equipment Directive (RED), the manufacturer or his authorized representative must use a conformity assessment procedure involving a notified body. A list of all harmonized standards is available on the European Commission’s website, which also gives information on titles and references to harmonised standards in relation to the RED.
Please note that nevertheless the only valid list is the most recent one published in the Official Journal of the European Union.
For any other case it is the manufacturers own choice to perform the conformity evaluation of his radio product by involving a notified body on a voluntary basis.
Market surveillance
The Member States of the European Union are forced to take appropriate measures to ensure that radio equipment covered by the Radio Equipment Directive (RED) placed on the market complies with the requirements of the Directive. Those measures also include market surveillance activities.