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4. Surveillance under the responsibility of the notified body

Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC Text with EEA relevance · European Union

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: the quality system documentation; the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.; the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out radio equipment tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.