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Regulations 46(4) and 52(2)

SCHEDULE 4U.K.Notified bodies

PART 1U.K.Notified Body Requirements

1.  A conformity assessment body must be established in the United Kingdom and have legal personality.U.K.

2.  A conformity assessment body must be a third party body independent of the organisation or the vessel it assesses. A body belonging to a business association or professional federation representing businesses involved in the design, manufacturing, provision, assembly, use or maintenance of vessels which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.U.K.

3.—(1) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the vessels that they assess, nor the representative of any of those parties.U.K.

(2) Sub-paragraph (1) does not preclude the use of assessed vessels that are necessary for the operations of the conformity assessment body or the use of such vessels for personal purposes.

4.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those vessels, or represent the parties engaged in those activities. They must not engage in any activity (including consultancy services) that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are [F1approved].

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

4.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those vessels, or represent the parties engaged in those activities. They must not engage in any activity (including consultancy services) that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.

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

5.  A conformity assessment body must ensure that the activities of its subsidiaries or sub-contractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.U.K.

6.  A conformity assessment body and its personnel must carry out conformity assessment activities with the highest degree of professional integrity and the requisite competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, particularly with regard to persons or groups of persons who have an interest in the results of those activities.U.K.

7.  A conformity assessment body must be capable of carrying out all of the conformity assessment activities for which it has been [F1approved], whether that assessment is carried out by the body itself or on its behalf and under its responsibility.

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

7.  A conformity assessment body must be capable of carrying out all of the conformity assessment activities for which it has been notified, whether that assessment is carried out by the body itself or on its behalf and under its responsibility.

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.  A conformity assessment body must have at its disposal:

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency of and the ability to reproduce those procedures, and have appropriate policies and procedures in place that distinguish between tasks it carries out as [F2an approved] body and other activities.

(c)procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

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

8.  A conformity assessment body must have at its disposal:

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency of and the ability to reproduce those procedures, and have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities.

(c)procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

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

9.  A conformity assessment body must have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to the necessary equipment or facilities.U.K.

10.  The personnel responsible for carrying out conformity assessment must have—

(a)sound technical and vocational training, covering all conformity assessment activities in relation to which the conformity assessment body has been [F1approved];

(b)satisfactory knowledge of the requirements of the assessments which the conformity assessment body carries out, and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the essential safety requirements, of the applicable [F3designated] standards and of the applicable provisions of F4... these Regulations; and

(d)the ability to draw up certificates, records and reports demonstrating that the assessments have been carried out.

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

10.  The personnel responsible for carrying out conformity assessment must have—

(a)sound technical and vocational training, covering all conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)satisfactory knowledge of the requirements of the assessments which the conformity assessment body carries out, and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the essential safety requirements, of the applicable harmonised standards and of the applicable provisions of the relevant Directives and of these Regulations; and

(d)the ability to draw up certificates, records and reports demonstrating that the assessments have been carried out.

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

11.  A conformity assessment body must be able to demonstrate the impartiality of its top level management and the personnel responsible for carrying out the conformity assessment activities.U.K.

12.  The remuneration of the top level management and the personnel responsible for carrying out the conformity assessment activities must not depend on the number of assessments carried out or on the results of those assessments.U.K.

13.  A conformity assessment body must have, and must satisfy the Secretary of State that it has, adequate civil liability insurance in respect of its activities.U.K.

14.  A conformity assessment body must ensure that its personnel observe professional secrecy with regard to all information obtained in carrying out their tasks in accordance with these Regulations, and that proprietary rights are protected.U.K.

15.  Paragraph 14 does not prevent the personnel from providing the information to the Secretary of State.U.K.

16.  A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of any [F1approved] body coordination group established [F5by the Secretary of State] and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

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

16.  A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of any notified body coordination group established under the Directive and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

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

PART 2U.K.Operational obligations of notified bodies

17.  [F6An approved] body must carry out conformity assessments in accordance with the conformity assessment procedures.

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

17.  A notified body must carry out conformity assessments in accordance with the conformity assessment procedures.

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

18.  [F7An approved] body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.

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

18.  A notified body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.

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

19.  [F8An approved] body must perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the vessel technology in question and the mass or serial nature of the production process.

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

19.  A notified body must perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the vessel technology in question and the mass or serial nature of the production process.

Extent Information

E25This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

20.  [F9An approved] body must respect the degree of rigour and the level of protection required to ensure that the vessel is in conformity with the requirements of these Regulations.

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

20.  A notified body must respect the degree of rigour and the level of protection required to ensure that the vessel is in conformity with the requirements of these Regulations.

Extent Information

E26This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

21.  Where [F10an approved] body finds that essential safety requirements or corresponding [F11designated] standards or other technical specifications have not been met by a manufacturer, it must require the manufacturer to take appropriate corrective measures and must not issue a certificate of conformity.

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

21.  Where a notified body finds that essential safety requirements or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it must require the manufacturer to take appropriate corrective measures and must not issue a certificate of conformity.

Extent Information

E27This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

22.  Where, in the course of the monitoring of conformity following the issue of a certificate of conformity, a notified body finds that a vessel is no longer in conformity with the essential safety requirements, it must require the manufacturer to take appropriate corrective measures and must, if necessary, suspend or withdraw the certificate of conformity.U.K.

23.  Where the [F1approved] body has required a manufacturer to take corrective measures and the manufacturer has failed to take such measures, or those measures have not had the required effect, the notified body must restrict, suspend or withdraw any certificate of conformity.

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

23.  Where the notified body has required a manufacturer to take corrective measures and the manufacturer has failed to take such measures, or those measures have not had the required effect, the notified body must restrict, suspend or withdraw any certificate of conformity.

Extent Information

E28This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

24.  Paragraph 25 applies where [F12an approved] body is minded to—

(a)refuse to issue a certificate of conformity;

(b)restrict, suspend or withdraw a certificate of conformity.

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

24.  Paragraph 25 applies where a notified body is minded to—

(a)refuse to issue a certificate of conformity;

(b)restrict, suspend or withdraw a certificate of conformity.

Extent Information

E29This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

25.  Where this paragraph applies, the [F1approved] body must—

(a)give the person applying for the certificate of conformity, or the person to whom the certificate of conformity has been given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;

(b)give the person referred to in sub-paragraph (a), an opportunity to make representations within a reasonable period from the date of the notice;

(c)take account of any representations made within the period referred to in subparagraph (b) before taking its decision.

Extent Information

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

Textual Amendments

25.  Where this paragraph applies, the notified body must—

(a)give the person applying for the certificate of conformity, or the person to whom the certificate of conformity has been given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;

(b)give the person referred to in sub-paragraph (a), an opportunity to make representations within a reasonable period from the date of the notice;

(c)take account of any representations made within the period referred to in subparagraph (b) before taking its decision.

Extent Information

E30This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

26.  [F13An approved] body must inform the Secretary of State of—

(a)any refusal, restriction, suspension or withdrawal of a certificate of conformity;

(b)any circumstances affecting the scope of or conditions for notification under regulation 46 F14...;

(c)any request for information which it has received from a market surveillance authority regarding conformity assessment activities;

(d)on request, any conformity assessment activities performed within the scope of its notification under regulation 46 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

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

Textual Amendments

26.  A notified body must inform the Secretary of State of—

(a)any refusal, restriction, suspension or withdrawal of a certificate of conformity;

(b)any circumstances affecting the scope of or conditions for notification under regulation 46 (notification);

(c)any request for information which it has received from a market surveillance authority regarding conformity assessment activities;

(d)on request, any conformity assessment activities performed within the scope of its notification under regulation 46 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E31This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

27.  [F15An approved] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—

(a)to refuse to issue a certificate of conformity or grant an approval;

(b)to restrict, suspend or withdraw a certificate of conformity or approval.

Extent Information

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

Textual Amendments

27.  A notified body must make provision in its contracts with its clients enabling such clients to appeal against a decision—

(a)to refuse to issue a certificate of conformity or grant an approval;

(b)to restrict, suspend or withdraw a certificate of conformity or approval.

Extent Information

E32This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

28.  [F16An approved] body must provide other bodies [F1approved] under these Regulations carrying out similar conformity assessment activities covering the same vessels with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Extent Information

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

Textual Amendments

28.  A notified body must provide other bodies notified under these Regulations carrying out similar conformity assessment activities covering the same vessels with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Extent Information

E33This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

29.  [F17An approved] body must participate in the work of any [F1approved] body coordination group established [F18by the Secretary of State], directly or by means of its designated representatives.

Extent Information

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

Textual Amendments

29.  A notified body must participate in the work of any notified body coordination group established under the Directive, directly or by means of its designated representatives.

Extent Information

E34This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only