Regulation (EU) 2018/858 — Approval and market surveillance…

Can our vehicles be blocked from EU registration if one system fails a surveillance check — and what does non-compliance cost per unit?

Since 1 September 2020, any non-compliant vehicle can be recalled EU-wide; the Commission may impose fines of up to EUR 30,000 per unit [Art. 85], and the manufacturer bears primary responsibility for conformity [Art. 13].

Short Answer

Regulation (EU) 2018/858 replaces Directive 2007/46/EC with a single EU-wide type-approval and market surveillance framework for motor vehicles (categories M, N), trailers (category O) and their systems, components and separate technical units [Art. 1]. Manufacturers, importers and distributors each carry specific conformity obligations [Art. 13, Art. 16, Art. 18], and market surveillance authorities must conduct a minimum of 1 compliance test per 40,000 new registrations, with at least 5 tests per year per Member State [Art. 8]. The Regulation has been materially amended by Reg. (EU) 2024/1257 (Euro 7 — strengthening emission requirements and penalty provisions), Reg. (EU) 2024/1689 (AI Act — requiring AI-safety considerations in delegated acts), Reg. (EU) 2024/1252 (Critical Raw Materials Act — adding permanent-magnet circularity to the type-approval table), Reg. (EU) 2024/1610 (introducing the e-trailer concept), Reg. (EU) 2022/2236 (software-update management), Reg. (EU) 2021/1244 and Reg. (EU) 2026/699 (standardised OBD/RMI access with cybersecurity framework), and Reg. (EU) 2026/1188 (Euro 7 Annex II integration and automated valet parking).

Who is affected

Any manufacturer, importer or distributor of motor vehicles (categories M1-M3, N1-N3), trailers (O1-O4), and their systems, components, separate technical units, parts or equipment intended for the EU market [Art. 2(1)]. Independent operators — repairers, spare-part distributors, diagnostic-tool manufacturers, technical-information publishers — are covered by the OBD/RMI access framework [Art. 3(45), Art. 61]. Technical services (testing laboratories, conformity-assessment bodies) designated by Member States must meet accreditation requirements and undergo assessment at least every 30 months [Art. 73, Art. 76]. Small-series exemptions apply: 1,500 units/year EU-wide for M1 and N1, 250 units/year per Member State for M1-N3 [Annex V].

Deadline

Next milestone: 7 July 2026 — registration prohibition for new complete vehicles without a compliant software-update management system [Annex II, as amended by Reg. (EU) 2022/2236]. Following: 29 November 2026 — Euro 7 applies to new types of M1/N1 vehicles [Reg. (EU) 2024/1257, Art. 17]. Then 29 November 2027 for all new M1/N1; 29 May 2028 for new types of M2/M3/N2/N3/O3/O4; 29 May 2029 for all new vehicles in those categories. Permanent-magnet circularity (Reg. (EU) 2024/1252) applies from 24 May 2029.

Risk

No EU-wide ceiling for Member-State-imposed penalties — each Member State sets its own sanctions, which must be effective, proportionate and dissuasive, proportionate both to the seriousness and the number of non-compliant units placed on the market [Art. 84(1)]. The Commission may impose administrative fines of up to EUR 30,000 per non-compliant vehicle, system, component or separate technical unit [Art. 85]. Type-approval can be withdrawn and affected vehicles recalled from the market under the safeguard procedure [Art. 52, Art. 53].

Proof

Legal status

• In force
• as of 2026-06-24
• Consolidated version of 1 July 2024, further amended by Reg. (EU) 2026/1188 (in force 22 June 2026) and Reg. (EU) 2026/699 (in force 23 June 2026)

Primary sources

• EUR-Lex — Full text
• European Commission — Vehicles — EU vehicle type approval

What to do now

Legal / DPO

•Audit all active EU type-approval certificates against the current Annex II requirements table, including software-update management (UN Reg. No 156) integrated by Reg. (EU) 2022/2236 and forthcoming Euro 7 requirements under Reg. (EU) 2024/1257 [Art. 5(1), Annex II]
•Assess penalty exposure under the expanded Art. 84 infringement catalogue: Reg. (EU) 2024/1257 added manufacturer-specific offences including defeat devices [Art. 84(3a)(b)] and missing excess-exhaust or low-reagent driver-warning systems [Art. 84(3a)(c)]
•Verify that OBD/RMI access agreements with independent operators comply with the non-discriminatory access obligation and the cybersecurity-aware framework from Reg. (EU) 2026/699 [Art. 61(1), Annex X]

Compliance

•Map the staged Euro 7 application dates (29 Nov 2026 for new M1/N1 types through 29 May 2029 for all M2/M3/N2/N3/O3/O4) and the software-update registration prohibition (7 July 2026) against the current vehicle portfolio [Annex II, Reg. (EU) 2024/1257 Art. 17]
•Maintain a documented conformity-of-production system — the approval authority may verify compliance at any time and withdraw type-approval if production deviates from the approved type [Art. 29, Art. 30]
•Implement an internal product-safety monitoring and recall process to detect non-compliance, inform the approval authority and market surveillance authorities, and execute corrective measures under the safeguard procedure where necessary [Art. 13(7), Art. 51, Art. 52]

IT / Security

•Prepare for the cybersecurity-aware OBD access framework under Reg. (EU) 2026/699: implement tool authentication, pseudonymised operator identification and access-traceability logging while preserving non-discriminatory access for independent repairers [Annex X]
•Ensure software-update management systems comply with UN Regulation No 156 as integrated via Reg. (EU) 2022/2236, including traceability and integrity verification of all over-the-air updates applied to type-approved vehicles [Annex II]
•For AI-equipped vehicles: when adopting delegated acts on technical requirements, the Commission must now account for high-risk AI system requirements (data governance, robustness, cybersecurity) per Art. 5(4) as inserted by the AI Act, Reg. (EU) 2024/1689 — ensure internal AI governance aligns with both frameworks [Art. 5(4)]

Product / Engineering

•Integrate permanent-magnet circularity requirements from the Critical Raw Materials Act, Reg. (EU) 2024/1252, into vehicle design — mandatory for all categories M, N and O as type-approval item G15 in the Annex II requirements table [Annex II, Part I]
•Plan product-line compliance for Euro 7: new emission limits, on-board monitoring, environmental vehicle passport and anti-tampering provisions apply from 29 November 2026 for new M1/N1 types [Reg. (EU) 2024/1257, Annex II as amended by Reg. (EU) 2026/1188]
•For e-trailers: ensure type-approval documentation covers propulsion and energy-storage system design as required by the definition in Art. 3(59) and the Annex I documentation requirements inserted by Reg. (EU) 2024/1610 [Art. 3(59), Annex I Part B]

Key Terms

EU type-approval: The procedure whereby a Member State approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the administrative and technical requirements of Regulation (EU) 2018/858 [Art. 3(2)].
Certificate of conformity: A document issued by the manufacturer certifying that a produced vehicle conforms to the approved vehicle type and complies with all regulatory acts applicable at the time of production [Art. 3(5)].
Independent operator: Any person or entity other than an authorised dealer or repairer involved in vehicle repair and maintenance — including repairers, spare-part distributors, diagnostic-tool manufacturers and technical-information publishers [Art. 3(45)].
Market surveillance: Activities and measures taken by national authorities to ensure vehicles, systems, components and separate technical units on the market comply with EU requirements and do not endanger health, safety or the environment [Art. 3(34)].
Conformity of production: The manufacturer's obligation to ensure that series production continuously matches the approved type, verified by the approval authority through documented procedures and periodic inspections [Art. 29, Art. 30].
Technical service: An organisation or body designated by the approval authority as a testing laboratory or conformity-assessment body to carry out tests, initial assessments and inspections for type-approval purposes [Art. 3(38)].
E-trailer: A trailer able to contribute to the propulsion of a vehicle combination via its own electric powertrain, incapable of independent use on public roads without active towing — introduced by Reg. (EU) 2024/1610 [Art. 3(59)].

Frequently Asked Questions

Who needs EU type-approval under this Regulation?

Any manufacturer placing motor vehicles (categories M, N), trailers (category O), or their systems, components and separate technical units on the EU market must hold a valid EU type-approval or individual vehicle approval [Art. 1, Art. 2]. Small-series and special-purpose vehicles may qualify for simplified procedures with lower annual unit limits [Art. 41, Art. 42, Annex V].

What are the obligations of importers?

Importers must verify that every product bears a valid EU type-approval certificate and approval mark before placing it on the market, and must refuse non-conforming products [Art. 16(1)-(3)]. They must indicate their name and contact address on the product or its packaging [Art. 16(5)] and keep records of complaints and recalls [Art. 16(7)].

Can independent repairers access vehicle diagnostic and repair data?

Yes. Manufacturers must provide unrestricted, standardised and non-discriminatory access to OBD information, diagnostic tools and repair/maintenance information to independent operators [Art. 61(1)]. Since 23 June 2026, this access is subject to the cybersecurity-aware framework under Reg. (EU) 2026/699, which allows manufacturers to require tool authentication while preserving the non-discriminatory access principle [Annex X as amended by Reg. (EU) 2026/699].

What penalties apply for placing non-approved vehicles on the market?

Member States set their own penalties, which must be effective, proportionate and dissuasive [Art. 84(1)]. Specific infringement categories include placing unapproved products on the market, falsifying test results, designing defeat devices, and vehicle tampering [Art. 84(2)-(3b), as amended by Reg. (EU) 2024/1257]. The Commission may impose additional fines of up to EUR 30,000 per non-compliant unit [Art. 85].

When do Euro 7 emission requirements apply?

Under Regulation (EU) 2024/1257 (Euro 7), which amends the Annex II requirements table: new types of M1/N1 vehicles from 29 November 2026; all new M1/N1 vehicles from 29 November 2027; new types of M2/M3/N2/N3/O3/O4 from 29 May 2028; all new vehicles in those categories from 29 May 2029 [Reg. (EU) 2024/1257, Art. 17].

What are the small-series exemptions?

EU small-series type-approval [Art. 41] allows simplified requirements for limited production volumes: 1,500 units/year EU-wide for categories M1 and N1. National small-series approval [Art. 42] allows 250 units/year per Member State for M1-N3, and 500 for O1-O2 trailers [Annex V]. Fully automated vehicles produced in small series are capped at 1,500 units/year EU-wide since 6 December 2022 [Annex V, as amended by Reg. (EU) 2022/2236].

How does the AI Act affect vehicle type-approval?

The AI Act (Reg. (EU) 2024/1689) inserts a new paragraph 4 into Article 5: when the Commission adopts delegated acts on vehicle technical requirements that concern AI systems which are safety components, it must take into account the high-risk AI system requirements of Chapter III, Section 2, of the AI Act — covering data governance, technical documentation, transparency, human oversight, accuracy, robustness and cybersecurity [Art. 5(4)].

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