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Regulation (EU) 2018/858 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (Text with EEA relevance)

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Regulation (EU) 2018/858 of the European Parliament and of the Council, CHAPTER XV is up to date with all changes known to be in force on or before 23 July 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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CHAPTER XVU.K. ASSESSMENT, DESIGNATION, NOTIFICATION AND MONITORING OF TECHNICAL SERVICES

Article 67U.K.Type-approval authority responsible for technical services

1.The approval authority F1..., shall be responsible for the assessment, designation, notification and monitoring of technical services, including, where appropriate, the subcontractors or subsidiaries of those technical services. The [F2approval] authority may decide that the assessment and monitoring of technical services and, where appropriate, of the subcontractors or subsidiaries of those technical services, is to be carried out by a national accreditation body.

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4.The [F5approval] authority shall not provide consultancy services on a commercial or competitive basis.

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Textual Amendments

Article 68U.K.Designation of technical services

1.The [F7approval authority must] designate technical services for one or more of the following categories of activities, depending on their field of competence:

(a)category A: tests referred to in this Regulation and in the regulatory acts listed in Annex II that technical services carry out in their own facilities;

(b)category B: the supervision of the tests, which includes test preparation, referred to in this Regulation and in the regulatory acts listed in Annex II, where such tests are performed at the manufacturer's facilities or at the facilities of a third party;

(c)category C: the assessment and monitoring on a regular basis of the procedures of the manufacturer for controlling the conformity of production;

(d)category D: the supervision or performance of tests or inspections for the surveillance of the conformity of production.

2.[F8The approval authority may designate itself] as a technical service for one or more of the categories of activities referred to in paragraph 1.

[F93.Subject to paragraph (3B), a technical service must have legal personality and must be established in—

(a)the United Kingdom;

(b)a member State; or

(c)the territory of a party to the CPTPP.]

[F103A.In paragraph (3) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.

3B.Paragraph (3) does not apply to a technical service belonging to an approval authority or an accredited in-house technical service of the manufacturer, as referred to in Article 72.]

4.A technical service shall take out liability insurance for its activities, [F11unless a state has assumed liability for those activities in accordance with its national law], or unless the [F12Secretary of State] itself is directly responsible for the conformity assessment.

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Textual Amendments

Article 69U.K.Independence of the technical services

1.A technical service, including its personnel, shall be independent and shall carry out the activities for which it has been designated with the highest degree of professional integrity and the requisite technical competence in the specific field in which it operates and shall be free from all pressures and inducements, particularly financial, that might influence its judgment or the results of its assessment activities, in particular such pressures or inducements emanating from persons or groups of persons with an interest in the results of those activities.

2.Technical services shall be third-party organisation or body that is not involved in the process of the design, manufacturing, supply or maintenance of the vehicle, system, component or separate technical unit that it assesses, tests or inspects.

An organisation or body that belongs to a trade association or to a professional federation representing undertakings that are involved in the design, manufacturing, supply or maintenance of the vehicles, systems, components or separate technical units that it assesses, tests or inspects, may be considered as fulfilling the requirements of the first subparagraph, provided that its independence and the absence of any conflict of interest are demonstrated to the [F14approval authority].

3.A technical service, its top-level management and the personnel responsible for carrying out the activities for which they are designated in accordance with Article 68(1) shall not design, manufacture, supply, or maintain the vehicles, systems, components or separate technical units that they assess, nor represent parties engaged in those activities. This shall not preclude the use of those vehicles, systems, components or separate technical units that are necessary for the operation of the technical service or the use of such vehicles, systems, components or separate technical units for personal purposes.

4.A technical service shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of the categories of activities for which it has been designated.

5.The personnel of a technical service shall observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the [F15approval] authority and, where relevant, to the national accreditation body, or where required by F16... law.

Textual Amendments

Article 70U.K.Competence of the technical services

1.A technical service shall be capable of carrying out all the activities for which it is applying to be designated in accordance with Article 68(1). It shall demonstrate to the [F17approval] authority or to the national accreditation body carrying out the assessment or monitoring of that technical service that it satisfies all of the following conditions:

(a)its personnel have the appropriate skills, the specific technical knowledge, the vocational training and sufficient and appropriate experience to perform the activities for which it is applying to be designated;

(b)it possesses descriptions of the procedures relevant for the performance of the activities for which it is applying to be designated, taking due account of the degree of complexity of the technology of the relevant vehicle, system, component or separate technical unit in question, as well as the mass or serial nature of the production process. The technical service shall demonstrate the transparency and reproducibility of those procedures;

(c)it has the necessary means to perform the tasks connected with the category or categories of activities for which it is applying to be designated, and it has access to all necessary equipment or facilities.

2.A technical service shall also demonstrate that it has the appropriate skills, the specific technical knowledge and proven experience to carry out tests and inspections for assessing the conformity of the vehicles, systems, components and separate technical units with this Regulation and shall demonstrate its compliance with the standards listed in Appendix 1 to Annex III. However, the standards listed in Appendix 1 to Annex III do not apply for the purposes of the last stage of a national multi-stage procedure referred to in Article 47(1).

3.[F18The Secretary of State may by regulations amend] Annex III as regards the requirements for the assessment of the technical services.

Textual Amendments

Article 71U.K.Subsidiaries of and subcontracting by technical services

1.Technical services may subcontract, with the agreement of the designating [F19approval] authority, some of the categories of activities for which they have been designated in accordance with Article 68(1), or have those activities carried out by a subsidiary.

2.Where a technical service subcontracts specific tasks within the categories of activities for which it has been designated or has a subsidiary perform those tasks, it shall ensure that the subcontractor or the subsidiary complies with the requirements set out in Articles 68, 69 and 70 and shall inform the [F19approval] authority thereof.

3.Technical services shall take full responsibility for the tasks performed by their subcontractors or subsidiaries, regardless of their place of establishment.

4.Technical services shall keep at the disposal of the F20... [F19approval] authority the relevant documents concerning the assessment carried out by the [F19approval] authority or the accreditation carried out by the national accreditation body of the subcontractor or the subsidiary and the tasks performed by them.

Textual Amendments

Article 72U.K.In-house technical service of the manufacturer

1.An in-house technical service of a manufacturer may be designated as a technical service for activities under category A as referred to in point (a) of Article 68(1), and only with regard to the regulatory acts listed in Annex VII. An in-house technical service shall constitute a separate and distinct part of the manufacturer's company and shall not be involved in the design, manufacturing, supply or maintenance of the vehicles, systems, components or separate technical units that it assesses.

2.An in-house technical service referred to in paragraph 1 shall comply with the following requirements:

(a)it has been accredited by a national accreditation body and complies with the requirements laid down in Appendices 1 and 2 to Annex III;

(b)the in-house technical service, including its personnel, is organisationally identifiable and has reporting methods within the manufacturer's company of which they form part that ensures its impartiality and demonstrates that impartiality to the relevant type-approval authority and to the national accreditation body;

(c)neither the in-house technical service nor its personnel is engaged in any activity that might conflict with its independence or with its integrity to perform the activities for which it has been designated;

(d)it supplies its services only to the manufacturer's company of which it forms part.

3.[F21The Secretary of State may by regulations amend] Annex VII to take account of technical and regulatory developments by updating the list of regulatory acts and restrictions contained therein.

Textual Amendments

Article 73U.K.Assessment and designation of technical services

1.The applicant technical service shall submit a formal application to the [F22approval] authority F23... in accordance with point 4 of Appendix 2 to Annex III. The application shall specify the categories of the activities for which the technical service is applying to be designated.

2.Before [F24the approval] authority designates a technical service, [F25the approval] authority or the national accreditation body shall assess it in accordance with an assessment check-list that covers at least the requirements laid down in Appendix 2 to Annex III. The assessment shall include an on-site assessment in the premises of the applicant technical service, and, where relevant, of any subsidiary or sub-contractor, whether located inside or outside the [F26United Kingdom].

3.In cases where the assessment is carried out by a national accreditation body, the applicant technical service shall deliver to the [F27approval] authority a valid accreditation certificate and the corresponding assessment report attesting that the technical service fulfils the requirements laid down in Appendix 2 to Annex III for the categories of activities for which the applicant technical service is applying to be designated.

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8.[F29The personnel of the approval authority carrying out an assessment must] produce after the on-site assessment a report setting out the extent to which the applicant technical service complies with the requirements laid down in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III.

9.The report referred to in paragraph 8 shall contain a summary of any identified non-compliances, together with a recommendation as to whether the applicant may be designated as technical service.

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15.The validity of the designation of technical services shall be limited to five years.

16.[F31Where the approval authority] intends to be designated as a technical service in accordance with Article 68(2) [F32it must] document compliance with this Regulation through an assessment conducted by independent auditors. Those auditors may be from within the same organisation provided that they are managed autonomously from the personnel undertaking the assessed activity, and provided that they comply with the requirements laid down in Appendix 2 to Annex III.

Textual Amendments

F33Article 74U.K.Notification to the Commission concerning designation of technical services

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Textual Amendments

Article 75U.K.Changes to and renewal of designations of technical services

1.Where the [F34approval] authority has ascertained or has been informed that a technical service no longer complies with the requirements laid down in this Regulation, that [F34approval] authority shall restrict, suspend or withdraw the designation, as appropriate, depending on the seriousness of the failure to comply with those requirements.

F35...

2.In the event of a restriction, suspension or withdrawal of the designation, or where the technical service has ceased its activity, the [F36approval] authority shall keep the files of that technical service available for the F37... market surveillance [F38authority] or transfer those files to another technical service chosen by the manufacturer in agreement with that technical service.

3.The [F39approval] authority shall assess within three months of [F40restricting, suspending or withdrawing the designation under] paragraph 1 whether the non-compliance of the technical service has an impact on [F41GB]   type-approval certificates issued on the basis of the inspection and test reports issued by [F42that technical service] F43....

Within two months after having [F44restricted, suspended or withdrawn] the designation, the [F45approval] authority shall [F46prepare] a report on its findings regarding the non-compliance F47.... Where necessary to ensure the safety of vehicles, systems, components or separate technical units already placed on the market, the F48... approval authority shall F49... suspend or withdraw within a reasonable period of time, any [F50GB]  type-approval certificates which were unduly issued.

[F514.Where the designation of a technical service has been restricted, suspended or withdrawn, but the approval authority has decided not to suspend or withdraw, in accordance with the second subparagraph of paragraph 3, the GB type-approval certificates which were issued on the basis of inspection and test reports issued by that technical service, those certificates remain valid unless the type-approvals have been invalidated in accordance with point (f) of Article 35(2).]

5.Extensions of the scope of the technical service's designation that lead to the designation of an additional category of activities referred to in Article 68(1) shall be assessed in accordance with the procedure set out in Article 73.

Extensions of the scope of a technical service's designation only for the regulatory acts listed in Annex II may be carried out in accordance with the procedures laid down in Appendix 2 to Annex III F52....

6.The designation of a technical service shall only be renewed after the [F53approval] authority has verified that the technical service continues to comply with the requirements of this Regulation. That assessment shall be carried out in accordance with the procedure set out in Article 73.

Textual Amendments

Article 76U.K.Monitoring of technical services

1.The F54... approval authority shall continuously monitor the technical services to ensure compliance with the requirements laid down in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III.

The first subparagraph of this paragraph shall not apply to any activities of technical services which are monitored by accreditation bodies in accordance with Article 67(1) for the purposes of ensuring compliance with the requirements laid down in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III.

Technical services shall supply on request all relevant information and documents that are required to enable the F54... approval authority or national accreditation body to verify compliance with those requirements.

Technical services shall inform the F54... approval authority or national accreditation body without delay of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III, or their ability to perform the conformity assessment tasks relating to the vehicles, systems, components and separate technical units for which they have been designated.

2.Technical services shall respond without delay to requests by [F55the approval] authority F56... in relation to the conformity assessments they have carried out.

3.The F57... approval authority shall ensure that the technical service carries out its obligation laid down in paragraph 2 of this Article, unless there is a legitimate reason for not doing so.

F58...

4.At least every 30 months, the [F59approval authority] shall assess whether each technical service under its responsibility continues to satisfy the requirements set out in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III. That assessment shall include an on-site assessment of each technical service under its responsibility.

F60...

Textual Amendments

F61Article 77U.K.Challenge to the competence of technical services

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Textual Amendments

F62Article 78U.K.Exchange of information on assessment, designation and monitoring of technical services

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Textual Amendments

Article 79U.K.Cooperation with national accreditation bodies

1.Where the designation of a technical service is based on accreditation within the meaning of Regulation (EC) No 765/2008, the national accreditation body and the [F63approval] authority shall fully cooperate and shall exchange relevant information in compliance with Regulation (EC) No 765/2008, including incident reports and other information that relate to matters under the control of the technical service when that information is relevant for the assessment of the performance of the technical service.

2.[F64The approval authority must keep] the national accreditation body in charge of the accreditation of a particular technical service informed of any findings that are relevant to the accreditation. The national accreditation body shall inform the [F65approval] authority F66... of its findings.

Textual Amendments

Article 80U.K.Operational obligations of technical services

1.Technical services shall carry out the activities for which they have been designated in accordance with Article 68(1).

2.At all times, technical services shall:

(a)allow the [F67approval] authority to witness the performance of the technical service during testing for type-approval; and

(b)where requested, provide the [F67approval] authority with information on the categories of activities for which they have been designated.

3.Where a technical service finds that a manufacturer does not comply with the requirements laid down in this Regulation, it shall report this non-compliance to the [F68approval] authority in order for that [F68approval] authority to require the manufacturer to take appropriate corrective measures. The [F68approval] authority shall refuse to issue a [F68approval] certificate where those appropriate corrective measures have not been taken.

Textual Amendments

Article 81U.K.Information obligations of technical services

1.Technical services shall inform the F69... approval authority of the following:

(a)any non-conformity encountered which may require the refusal, restriction, suspension or withdrawal of a type-approval certificate;

(b)any circumstances affecting the scope of and conditions for their designation;

(c)any request for information which they have received from market surveillance authorities regarding their activities.

2.Upon request from the F69... approval authority, technical services shall provide information on the activities within the scope of their designation or on any other activity they have performed, including cross-border activities and subcontracting.

Textual Amendments

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