According to Directive 2014/53/EU (RED), radio equipment must comply with the essential safety requirements (ESR) before being placed on the EU market. Manufacturers should ensure that their products meet the essential requirements for safety and health, electromagnetic compatibility, and the efficient use of the radio spectrum. The Directive also introduces the basis for further regulation concerning some additional aspects. These include technical features for the protection of privacy, personal data and against fraud. Furthermore, additional aspects cover interoperability, access to emergency services, and compliance regarding the combination of radio equipment and software.
The notified body must be involved in the conformity assessment procedures. To meet the above requirements of the Directive, CerTrust Ltd. has well-known expertise in testing and certification services on the field of radio equipment. Our certification process bases on the harmonized standards of the European Union. We are a notified body in the European Union in the conformity assessment procedures for radio equipment devices and we are actively involved in the regular meetings of the notified bodies, the standardization committees, so we are up to date on the latest developments in the area and regulations. Our experts are internationally recognized, not to mention that we are in daily contact with manufacturers, distributors, and importers. Our RED certificates cover all categories of the directive.
Radio equipment is defined in Article 2.1(1) of the RED 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, to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radio determination. The European Union harmonization legislation defines the manufacturer, the authorized representative, the importer, and the distributor as „economic operators”. Clearly the manufacturer has the main responsibility. The other operators have their obligations with regards to those of the manufacturer.
a) Ensure radio equipment is designed and manufactured in accordance with the essential requirements in article 3 of the RED (see Chapter 2.6.a)
b) Carry out conformity assessment procedures (see Chapter 2.6.b)
c) Ensure that the equipment can operate in at least one Member State (see Chapter 2.6.c)
d) Draw up technical documentation according to Article 21 (see Chapter 2.6.d)
e) Draw up a Declaration of Conformity (DoC) / simplified DoC which shall accompany the product (see Chapter 2.6.e)
f) Affix CE marking and notified body number if applicable (see Chapter 2.6.f)
g) Add type or batch or serial number or other element to the equipment allowing its identification (see Chapter 2.6.g)
h) Add traceability information to the equipment (address, etc…) (see Chapter 2.6.h)
i) Add geographical information in case of restrictions (see Chapter 2.6.i)
j) Ensure that the equipment is accompanied by instructions and safety information including, where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended. These instructions shall also include information about the frequency bands and power used by the radio equipment. (see Chapter 2.6. j)
k) Ensure that series of production remain in conformity with the Directive (see Chapter 2.6.k)
l) When deemed appropriate, carry out sample testing of radio equipment made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, and shall keep distributors informed of any such monitoring. (see Chapter 2.6.l)
m) Take immediate actions in case of non-compliance of products already placed on the market. (see Chapter 2.6.m)
n) Cooperate with competent national authorities. (see Chapter 2.6.n)
A manufacturer may, by a written authorization, appoint an authorized representative established in the EU to take over some of his responsibilities. This authorization shall at least include the obligation to keep the 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 the obligations mentioned above may be transferred as well.
This economic operator of the radio equipment must ensure that the company is only placing compliant equipment on the market and that the manufacturer has followed correctly his obligations resulting from the RED.
The distributor shall act in accordance with the RED when making radio equipment available on the market which includes but not limited to providing the correct labelling with complete instructions and safety information. The company shall ensure that the manufacturer has followed his obligations in due diligence
EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of radio equipment, verifies, and certifies that the technical design of radio equipment complies with the applicable requirements of the Directive, the technical documentation submitted, the design, manufacture, and operation of radio equipment. This shall be done by examining the supporting criteria, assessing the conformity of the technical design of the radio equipment, without testing a sample (design type).
The manufacturer shall lodge an application for EU-type examination with a notified body of his choice.
Conformity to type based on internal production control is the part of the conformity assessment procedure whereby the manufacturer fulfills the obligations arising out of the manufacturing, CE marking and EU declaration of conformity and ensures and declares that the radio equipment concerned is in conformity with the type as described in the EU-type examination certificate.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured radio equipment with the above requirements.
Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfills the obligation to operate an approved quality system for design, manufacture, final inspection and testing of the radio equipment concerned as specified in RED. It must also enable the notified body to enter the manufacturing, inspection, testing and storage sites for assessment and to provide it with all the necessary technical documentation.
The Radio Equipment Directive was published in the EU on 22 May 2014, entered into force on 11 June 2014 and is applicable from 13 June 2016. During a one-year transitional period, which ended on 12 June 2017 (Article 48), manufacturers were allowed to place radio equipment on the market compliant with either the RED or the EU legislation applicable before 13 June 2016 (e.g. R&TTED).