The Radio Equipment Regulations 2017

Module B

EU-type examination

1.  EU-type examination is the part of a conformity assessment procedure in which 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.

2.  EU-type examination must be carried out by assessment of the adequacy of the technical design of the radio equipment through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen (design type).

3.—(1) The manufacturer must lodge an application for EU-type examination with a single notified body of the manufacturer’s choice.

(2) The application must include:

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the representative’s name and address as well;

(b) a written declaration that the same application has not been lodged with any other notified body;

(c) the technical documentation. The technical documentation shall make it possible to assess the radio equipment’s conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the radio equipment. The technical documentation must contain, wherever applicable, the elements set out in Schedule 5 (contents of technical documentation);

(d) the supporting evidence for the adequacy of the technical design solution. That supporting evidence must mention any documents that have been used, in particular where the relevant harmonised standards have not been applied or have not been fully applied. The supporting evidence must include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer’s behalf and under the manufacturer’s responsibility.

4.  The notified body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment.

5.  The notified body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations as provided in paragraph 8, the notified body must release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.—(1) Where the type meets the requirements of these Regulations that apply to the radio equipment concerned, the notified body must issue an EU-type examination certificate to the manufacturer. That certificate must contain—

(a) the name and address of the manufacturer,

(b) the conclusions of the examination,

(c) the aspects of the essential requirements covered by the examination,

(d) the conditions (if any) for its validity, and

(e) the necessary data for identification of the assessed type.

(2) The EU-type examination certificate may have one or more annexes attached.

(3) The EU-type examination certificate and its annexes must contain all relevant information to allow the conformity of manufactured radio equipment with the examined type to be evaluated and to allow for in-service control.

(4) Where the type does not satisfy the applicable requirements of these Regulations, the notified body must refuse to issue an EU-type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

7.—(1) The notified body must keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation. If so, the notified body must inform the manufacturer accordingly.

(2) The manufacturer must inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the radio equipment with the essential requirements of these Regulations or the conditions for validity of that certificate. Such modifications require additional approval in the form of an addition to the original EU-type examination certificate.

8.—(1) Each notified body must inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and must, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

(2) Each notified body must inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

(3) Each notified body must inform the Member States of EU-type examination certificates it has issued and/or additions thereto in those cases where harmonised standards the references of which have been published in the Official Journal have not been applied or not been fully applied. The Member States, the European Commission and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Member States and the European Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body must keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for 10 years after the radio equipment has been assessed or until the expiry of the validity of that certificate.

9.  The manufacturer must keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market.

10.  The manufacturer’s authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 7 and 9, provided that they are specified in the mandate.