Radio equipment within certain categories or classes shall be so constructed that it complies with the essential requirements of Directive 2014/53/EU.
Before placing radio equipment on the market importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer and shall ensure that the manufacturer has drawn up the technical documentation.
Radio equipment which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the EU shall be presumed to be in conformity with the essential requirements set out in Article 3 covered by those standards or parts thereof.
Manufacturers shall demonstrate compliance of radio equipment with the essential requirements using any of the following conformity assessment procedures:
Module A. Internal production control. The manufacturer shall establish the technical documentation, take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured radio equipment with the technical documentation, shall affix the CE marking and draw up a written EU declaration of conformity.
Module B. EU-type examination. A notified body examines the technical design of the radio equipment and verifies and attests that the technical design of the radio equipment meets the essential requirements.
Module C. Conformity to type based on internal production control. Module C covers only the production phase and follows module B. The part of a conformity assessment procedure whereby the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured radio equipment with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to it, shall affix the CE marking and draw up a written EU declaration of conformity.
Module H. Conformity based on full quality assurance. The manufacturer shall operate an approved quality system for design, manufacture, final radio equipment inspection and testing of the radio equipment. The quality system shall ensure compliance of the radio equipment with the requirements of Directive.
Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive.
The lists of notified bodies are given in NANDO (New Approach Notified and Designated Organisations) information system https://ec.europa.eu/growth/tools-databases/nando/.
Updated on 2022-05-02