Regulation (EU) 2018/858: the core framework for European vehicle approval
Regulation (EU) 2018/858 establishes the European Union framework for the approval and market surveillance of motor vehicles and their trailers, together with the systems, components and separate technical units intended for those vehicles.
It applies to the type approval and placing on the market of new vehicles and related systems, components and separate technical units, and also establishes the framework for individual vehicle approvals.
The Regulation replaced Directive 2007/46/EC and has applied across the European Union since 1 September 2020. It is therefore one of the central legal instruments for manufacturers seeking access to the European automotive market.
What does Regulation (EU) 2018/858 cover?
The Regulation establishes administrative procedures and approval requirements for:
Under Article 3, EU type approval is the procedure whereby an approval authority certifies that a vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements of the Regulation.
EU Whole Vehicle Type Approval — WVTA
The EU Whole Vehicle Type Approval system allows a manufacturer to obtain approval for a vehicle type through an approval authority in one Member State and subsequently place vehicles conforming to that approved type on the EU market, subject to the applicable requirements.
A vehicle type approved in one EU country can be marketed throughout the European Union without repeating the entire approval process in each Member State.
The approval process normally combines:
- Vehicle technical documentation
- EU and/or UN type approvals for systems and components
- Technical-service testing
- Whole-vehicle assessment
- Conformity of Production arrangements
- Approval-authority review and issue of the EU type-approval certificate
Regulation (EU) 2018/858 provides for different approval procedures:
- Step-by-step type approval
- Single-step type approval
- Mixed type approval
- Multi-stage type approval
The information folder and approval documentation
A manufacturer applying for EU type approval must prepare the information required for the approval process. Article 24 requires the information folder to contain the information document and the technical information necessary for the approval authority to identify the type and conduct the type-approval procedure.
Depending on the approval route, this documentation may include:
- Technical descriptions and drawings
- Photographs
- Vehicle configuration data
- EU type-approval certificates
- UN type-approval certificates
- Test reports
- Supporting technical documentation
Article 25 establishes additional information requirements for step-by-step, mixed and multi-stage approvals.
Technical testing
Compliance with the applicable technical requirements is demonstrated through testing and assessment performed in the framework established by Regulation (EU) 2018/858 and the regulatory acts listed in Annex II.
Article 30 establishes that the approval authority verifies compliance through appropriate tests performed by its technical services.
Technical services play a central role in:
- Carrying out approval tests
- Conformity assessments
- Inspections and technical evaluation
- Preparation of test reports supporting the approval decision
Conformity of Production — COP
Obtaining an approval is not sufficient by itself. The manufacturer must also demonstrate that vehicles, systems and components produced in series continue to conform to the approved type.
Article 26 requires the approval authority, before granting an EU type approval, to verify the Conformity of Production arrangements referred to in Article 31.
The COP system may include:
- Manufacturing controls and inspection plans
- Production testing
- Traceability and control of approved specifications
- Management of production changes
- Corrective actions
- Periodic verification by the approval authority or its designated bodies
Certificate of Conformity — CoC
The Certificate of Conformity links series production with the approved vehicle type. For vehicles manufactured in conformity with an approved type, the manufacturer issues a Certificate of Conformity containing the principal characteristics and technical data of the vehicle.
Regulation (EU) 2018/858 includes both paper and electronic CoC provisions.
eCoC requirements from 5 July 2026
Regulation (EU) 2018/858 establishes the transition toward electronic Certificates of Conformity.
From 5 July 2026, Article 37 requires manufacturers to make the Certificate of Conformity available to the approval authority that granted the whole-vehicle type approval as structured electronic data, free of charge and without undue delay after manufacture.
Key points:
- The approval authority must make the electronic CoC available so that it can be accessed by approval authorities, market-surveillance authorities, registration authorities of Member States and the European Commission.
- Member States must be capable of exchanging electronic Certificates of Conformity with other Member States from 5 July 2026.
- From that date, the manufacturer may be exempt from providing the paper CoC accompanying every vehicle where the certificate is made available electronically in accordance with Article 37.
Vehicles produced in small series
Regulation (EU) 2018/858 establishes two relevant small-series routes:
EU small-series type approval (Article 41) — Provides for EU type approval of vehicles produced in small series within the applicable quantitative limits and technical requirements.
National small-series type approval (Article 42) — Allows manufacturers to apply for national small-series type approval within the applicable annual limits. Member States may establish alternative requirements. The geographical validity differs from EU WVTA.
Individual Vehicle Approval — IVA
Regulation (EU) 2018/858 distinguishes between EU individual vehicle approval and national individual vehicle approval.
EU individual vehicle approval (Article 44) — For vehicles complying with the requirements in Appendix 2 to Part I of Annex II, or the relevant special-purpose-vehicle provisions. A vehicle holding a valid EU individual vehicle approval certificate can be placed on the market in Member States in accordance with the Regulation.
National individual vehicle approval (Article 45) — Member States may establish national individual vehicle approval using relevant alternative requirements. Under Article 46, such approval is initially territorially restricted to the Member State granting it, with a mechanism for recognition in another Member State.
Changes to an approved vehicle type and validity
Changes to approved types (Article 34):
Manufacturers must manage changes to approved types carefully. Article 34 distinguishes between revisions and extensions. An extension may be required where additional testing is necessary, information in the certificate changes, or new applicable regulatory requirements become relevant.
Validity of EU type approvals (Article 35):
An EU type approval may become invalid in situations including: new mandatory requirements become applicable; the approved type no longer satisfies relevant regulatory acts; production is definitively discontinued; an approval is withdrawn; or the approval was based on false declarations or falsified test results.
For whole-vehicle approvals, manufacturers must continuously monitor regulatory changes throughout the life of the vehicle type.
Market surveillance and post-approval obligations
Regulation (EU) 2018/858 is not limited to the approval phase. It also establishes a stronger EU market-surveillance framework covering vehicles and related systems, components and separate technical units already placed on the market.
Where non-conformity or a serious risk is identified, manufacturers may be required to take corrective action, withdraw products from the market or carry out recalls.
The Regulation strengthened:
- Independence and quality of type approval and testing
- Checks on vehicles already on the EU market
- European oversight of the approval system
Regulation (EU) 2018/858 and UNECE approvals
European whole-vehicle approval normally combines EU regulatory requirements with approvals obtained under applicable UN Regulations. Regulation (EU) 2018/858 expressly recognises EU and UN type-approval certificates in the approval documentation framework under Annex II.
For manufacturers entering Europe, the approval strategy should identify:
- Existing UN approvals
- Missing EU/UN approvals
- Vehicle-level and component-level requirements
- Additional EU-specific requirements
- COP implications
Regulation (EU) 2018/858 for Chinese vehicle manufacturers
For a Chinese vehicle manufacturer entering the European Union, existing Chinese approvals, GB standards or CCC certification do not automatically constitute EU whole-vehicle type approval.
A European market-entry programme normally requires a regulatory gap analysis between the vehicle specification and the applicable EU and UNECE requirements.
Typical activities include:
- GB / UNECE regulatory gap analysis
- Review of existing test reports and approvals
- Identification of missing homologation activities
- Coordination with technical services
- Preparation of vehicle approval documentation
- COP preparation
- Support during the whole-vehicle approval process
How LEBBA Automotive supports manufacturers
LEBBA Automotive supports vehicle manufacturers through the practical implementation of European and UNECE homologation requirements. Services include:
- Regulatory gap analysis
- EU type-approval strategy
- WVTA project coordination
- Technical documentation review
- Test planning and coordination with technical services
- Support with approval authorities
- Conformity of Production preparation and audits
- Individual and small-series approval support
- China-to-Europe homologation programmes
- Regulatory monitoring
Regulatory Reference
- Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018
- Current consolidated version verified: 02 August 2026
- CELEX: 02018R0858-20260802
- Original publication: OJ L 151, 14 June 2018
*This technical guide is intended as a practical overview. For approval decisions, the applicable legal text, the regulatory acts listed in Annex II and their current amendments must always be verified.*