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The Radio Equipment Regulations 2017

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Regulation 41(4)(b)

SCHEDULE 3U.K.Conformity assessment modules B and C

This schedule has no associated Explanatory Memorandum

[F1EU-type] [F1Type] examination and conformity to type based on internal production controlU.K.

Textual Amendments

When reference is made to this Schedule, the conformity assessment procedure must follow Modules B ([F1EU-type] [F1Type] examination) and C (Conformity to type based on internal production control) of this Schedule.

Module BU.K.

[F1Type] examinationE+W+S

1.  [F2Type] 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.

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EU-type examinationN.I.

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.

Extent Information

E13This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

2.  [F3Type] 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).E+W+S

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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).N.I.

Extent Information

E14This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

3.—(1) The manufacturer must lodge an application for [F4Type] examination with a single [F5approved] body of the manufacturer's choice.E+W+S

(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 [F6approved] 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 [F7designated] 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.

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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

(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.

Extent Information

E15This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

4.  The [F8approved] body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment.E+W+S

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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

Extent Information

E16This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

5.  The [F9approved] 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 [F9approved] body must release the content of that report, in full or in part, only with the agreement of the manufacturer.E+W+S

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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.N.I.

Extent Information

E17This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.—(1) Where the type meets the requirements of these Regulations that apply to the radio equipment concerned, the [F10approved] body must issue [F11a Type] examination certificate to the manufacturer. That certificate must contain—E+W+S

(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 [F12Type] examination certificate may have one or more annexes attached.

(3) The [F13Type] 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 [F14approved] body must refuse to issue [F15a Type] examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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—N.I.

(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.

Extent Information

E18This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

7.—(1) The [F16approved] 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 [F16approved] body must inform the manufacturer accordingly.E+W+S

(2) The manufacturer must inform the [F16approved] body that holds the technical documentation relating to the [F17Type] 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 [F17Type] examination certificate.

Extent Information

E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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.N.I.

(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.

Extent Information

E19This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

8.—(1) Each [F18approved] body must inform [F19the Secretary of State] concerning the [F20Type] examination certificates and/or any additions thereto which it has issued or withdrawn, and must, periodically or upon request, make available to [F19the Secretary of State] the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.E+W+S

(2) Each [F18approved] body must inform the other [F18approved] 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 [F18approved] body must inform the [F21Secretary of State and the other approved bodies] of [F22Type] examination certificates it has issued and/or additions thereto in those cases where [F23designated] standards F24... have not been applied or not been fully applied. The [F25Secretary of State] and the other [F18approved] bodies may, on request, obtain a copy of the [F22Type] examination certificates and/or additions thereto. On request, the [F26Secretary of State] may obtain a copy of the technical documentation and the results of the examinations carried out by the [F18approved] body. The [F18approved] body must keep a copy of the [F22Type] 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.

Extent Information

E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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.N.I.

(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 [F37relevant 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 [F37relevant 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 [F37relevant 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.

Extent Information

E20This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

9.  The manufacturer must keep a copy of the [F27Type] examination certificate, its annexes and additions together with the technical documentation at the disposal of the [F28enforcing] authorities for 10 years after the radio equipment has been placed on the market.E+W+S

Extent Information

E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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.N.I.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

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.U.K.

Module CU.K.

Conformity to type based on internal production controlE+W+S

11.  Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 3, and ensures and declares that the radio equipment concerned is in conformity with the type described in the [F29Type] examination certificate and satisfies the requirements of these Regulations that apply to it.

Extent Information

E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Conformity to type based on internal production controlN.I.

11.  Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 3, and ensures and declares that the radio equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of these Regulations that apply to it.

Extent Information

E22This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

ManufacturingE+W+S

12.  The manufacturer must 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 [F30Type] examination certificate and with the requirements of these Regulations that apply to it.

Extent Information

E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

ManufacturingN.I.

12.  The manufacturer must 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 these Regulations that apply to it.

Extent Information

E23This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F31UK] marking and F32... declaration of conformityE+W+S

13.—(1) The manufacturer must affix the [F33UK] marking in accordance with regulations 39 (prohibition on improper use of [F33UK] marking) and 44 ([F33UK] marking) to each item of radio equipment that is in conformity with the type described in the [F34Type] examination certificate and satisfies the applicable requirements of these Regulations.

(2) The manufacturer must draw up a written F35... declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The F35...declaration of conformity must identify the radio equipment type for which it has been drawn up.

(3) A copy of the F36... declaration of conformity must be made available to the relevant authorities upon request.

Extent Information

E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

CE marking and EU declaration of conformityN.I.

13.—(1) The manufacturer must affix the CE marking in accordance with regulations 39 (prohibition on improper use of CE marking) and 44 (CE marking) to each item of radio equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of these Regulations.

(2) The manufacturer must draw up a written EU declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The EU declaration of conformity must identify the radio equipment type for which it has been drawn up.

(3) A copy of the EU declaration of conformity must be made available to the relevant authorities upon request.

Extent Information

E24This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Authorised representativeU.K.

14.  The manufacturer's obligations set out in paragraph 3 may be fulfilled by the manufacturer's authorised representative, on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate.

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