In Europe there is a single market which covers all European Union Countries and EFTA Countries. The requirements for accessing this market (CE Marking) are in form of Directives. Several directives can apply at the same time to a given product depending on its nature. 
All devices that intentionally transmit or receive radio waves (with a few exceptions, including radio equipment for naval vessels, public-safety and government equipment, and some aeronautical devices) must comply with the requirements set in the 2014/53/EU Radio Equipment Directive.

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Summary of Radio Equipment Directive (RED)

The technical requirements of the European Directives appear in the form of Essential requirements, included in Article 3 of Directive 2014/53/EU. Radio equipment shall be constructed so as to ensure:

Article 3.1(a): the protection of the health and safety of people and of domestic animals and the protection of property, including the objectives regarding safety requirements set out in Directive 2014/35/EU, but with no applicable voltage limit;

Article 3.1(b): an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU.

Article 3.2: that it effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.

Article 3.3: other requirements for certain categories or classes of Radio Equipment.

There are three ways in which manufacturers and importers can ensure that a product or product range complies with the key requirements of the Directive or the essential requirements. Two of these require the intervention of a Notified Body.

  • Module A – Internal production control: The manufacturer is responsible for drawing up the technical documentation (which must include proof of conformity testing to the relevant product standards), carrying out an internal production control and issuing a declaration of conformity. This module is only available where products have been tested, completely, to Harmonised Standards.
  • Modules B + C – EU-type examination (B) and Conformity to type based on internal production control (C): These modules make the same demands on the manufacturer as module A, but a Notified Body is required (for module B) to examine the resulting technical documentation and to issue an EU-type examination certificate for the product in question. The use of these modules is mandatory for the introduction into the EU market of any product that has not been tested, completely, to Harmonised Standards. They can also be used, on a voluntary basis, for products that have been tested to Harmonised Standards. Either way, they may only be used for the conformity assessment of a product type.
  • Module H – Full quality assurance: The manufacturer implements and manages a quality system encompassing radio equipment design, testing and manufacturing processes, which is subsequently assessed, certified and monitored by a Notified Body through periodic audits of the manufacturing plant. This module permits the conformity testing of a whole range of products, even of several different product ranges, and also allows the Notified Body number to be shown alongside the product’s CE Marking.

Many countries worldwide that do not have their own Radio Type Approval regulations refer to European regulations (2014/53/EU), and require an EU-type examination certificate. Therefore when addressing a worldwide homologation project, the Modules B + C approach is recommended.

Labelling Requirements

Once a product has been proved to comply with the essential requirements of the applicable Directives by means of one of the three paths defined above, the product shall be labelled with the CE mark:

Applus+ Notified Body Services for RED

For Modules B+C, the Radio Equipment Technical File is evaluated by Applus+ as a Notified Body. Applus will issue an EU Type Examination Certificate for the evaluated product.

For Module H, the product family is registered in the Applus+ QA records and marked by the manufacturer with the Applus+ Notified Body number.  

 
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