Regulation (EU) 2018/858 — Type-Approval and Market Surveil

Do our vehicles still meet EU type-approval requirements — and what happens if market surveillance finds they don't?

Regulation (EU) 2018/858 has been fully applicable since 1 September 2020 — the Commission can impose administrative fines of up to EUR 30,000 per non-compliant vehicle, system or component, and your compliance or homologation team should verify conformity of production now [Art. 85(1)].

Short Answer

Regulation (EU) 2018/858 replaced Directive 2007/46/EC as the EU framework for whole-vehicle type-approval and market surveillance of motor vehicles (categories M, N, O), their trailers, and systems, components and separate technical units [Art. 1, Art. 2(1)]. It strengthened oversight by requiring Member States to conduct a minimum number of market surveillance tests per year — at least one per 40,000 new registrations, but never fewer than five [Art. 8(2)]. Manufacturers must appoint an EU-based representative if established outside the Union [Art. 13(4)] and must not design vehicles with strategies that alter performance during test procedures so as to circumvent compliance [Art. 13(5)]. Manufacturers, importers, and distributors each carry specific obligations to immediately report serious risks and cooperate with corrective measures [Art. 14, Art. 17, Art. 19].

Who is affected

Manufacturers of motor vehicles (category M, N) and trailers (category O), along with manufacturers of systems, components and separate technical units for such vehicles, as well as importers, distributors, and independent operators (repairers, aftermarket part providers) operating in the EU market [Art. 2(1), Art. 3]. Non-EU manufacturers must appoint an authorised representative established in the Union [Art. 13(4)]. Agricultural, forestry, two/three-wheeled vehicles, track-laying vehicles and military vehicles are excluded [Art. 2(2)].

Deadline

Fully applicable since 1 September 2020 [Art. 91]. Ongoing obligations: market surveillance authorities must submit planned checks to the Forum by 1 March each year [Art. 8(6)]; manufacturers must ensure continuous conformity of production [Art. 13(6), Art. 31]; annual penalty reporting by Member States to the Commission [Art. 84(4)]. Latest amendments via Regulation (EU) 2024/1257 and Regulation (EU) 2024/1610 have added enhanced provisions on manipulation devices and exhaust emissions driver warning systems.

Risk

The Commission may impose administrative fines of up to EUR 30,000 per non-compliant vehicle, system, component or separate technical unit [Art. 85(1)]. Member States must lay down effective, proportionate and dissuasive penalties for infringements including false declarations, falsified test results, withholding recall-relevant data, selling unapproved products and vehicle tampering [Art. 84(1)–(3b)]. Market surveillance authorities may prohibit market placement, withdraw products or order recalls [Art. 52(3)]. Using manipulation devices that make a non-compliant vehicle appear compliant is a separately penalised offence [Art. 84(3a)(b)].

Proof

Legal status

• In force
• as of 2026-04-19
• Consolidated version of 01.07.2024 (incorporating amendments up to Regulation (EU) 2024/1610)

Primary sources

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

What to do now

Legal / DPO

•Verify that all EU type-approval certificates remain valid and that the manufacturer's representative mandate covers the obligations in Art. 15(1), including cooperation with market surveillance authorities and whistleblower-style termination rights [Art. 15(1)(e)].
•Review penalty exposure: ensure the organisation's internal legal framework accounts for the infringement categories in Art. 84(2)–(3a), especially the prohibition on manipulation devices and falsified in-service conformity test results [Art. 84(3a)(a)–(b)].
•Confirm that vehicle OBD and repair/maintenance information is made available to independent operators on a non-discriminatory basis as required by Art. 61(1), including remote diagnostic services — non-compliance triggers enforcement under Chapter XIV [Art. 65].

Compliance

•Map every vehicle type and variant to its EU type-approval certificate; ensure conformity of production procedures are documented, audited and available for inspection within the 10-year retention period for vehicles [Art. 14(3), Art. 31].
•Establish a complaints and recall tracking register covering all vehicles, systems and components placed on the market, and ensure distributors and importers are informed of substantiated complaints [Art. 13(7), Art. 17(7)].
•Prepare the annual market surveillance overview that must be submitted to the Forum by 1 March and ensure that internal emission-related test records cover at least 20% of the minimum test quota [Art. 8(2)–(3), Art. 8(6)].

IT / Security

•Ensure that access to software, algorithms and electronic control units is provided to market surveillance authorities upon request — refusal constitutes a penalised infringement [Art. 8(8), Art. 84(3)(a)].
•Implement a secure, standardised remote facility enabling independent repairers to complete operations involving the vehicle security system, as mandated by Art. 61(1) second subparagraph.
•Maintain the integrity of on-board diagnostic (OBD) data interfaces and ensure that no software update alters test-relevant performance in a way that could be classified as a manipulation strategy [Art. 13(5), Art. 84(3a)(b)].

Product / Engineering

•Ensure that every vehicle leaving the production line carries a valid certificate of conformity and statutory plate with the manufacturer's name and EU contact address [Art. 36, Art. 13(8)].
•Verify that systems, components and separate technical units bear the correct type-approval marks and that no product is made available on the market without the required approval — doing so triggers penalties [Art. 84(3)(b)].
•Coordinate with the type-approval authority on any extension, amendment or withdrawal of type-approvals triggered by design changes, and ensure multi-stage or step-by-step approval documentation is complete [Art. 29, Art. 33, Art. 34].

Key Terms

Type-approval: Procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements [Art. 3(1)].
EU type-approval: Type-approval certifying compliance specifically with the provisions of Regulation (EU) 2018/858, valid across all EU Member States without further national approval [Art. 3(2)].
Certificate of conformity: Document issued by the manufacturer certifying that a produced vehicle conforms to the approved type and complies with all regulatory acts applicable at the time of production [Art. 3(5)].
Market surveillance: Activities and measures taken by national market surveillance authorities to verify that vehicles and components on the market comply with EU harmonisation requirements and do not endanger health, safety or the environment [Art. 3(42)].
Technical service: Third-party organisation designated by a Member State to perform testing, inspection or conformity assessment activities on behalf of the type-approval authority, subject to independence and competence requirements [Art. 68, Art. 69].
Whole-vehicle type-approval: Procedure certifying that an incomplete, complete or completed type of vehicle satisfies all relevant administrative provisions and technical requirements as a whole [Art. 3(7)].
Economic operator: Collective term for the manufacturer, the manufacturer's representative, the importer and the distributor in the vehicle supply chain, each bearing specific obligations under the Regulation [Art. 3].

Frequently Asked Questions

Which vehicle categories are covered by Regulation (EU) 2018/858?

The Regulation applies to motor vehicles of categories M (passenger) and N (goods), their trailers of category O, and all systems, components and separate technical units intended for such vehicles. Agricultural/forestry vehicles, two/three-wheelers, track-laying vehicles and military vehicles are excluded [Art. 2(1)–(2)].

What are the minimum market surveillance testing requirements?

Each Member State must carry out at least one test per 40,000 new motor vehicles registered in the preceding year, with a minimum of five tests per year. At least 20% of tests exceeding the five-test floor must be emission-related tests comparable to type-approval tests [Art. 8(2)–(3)].

Can the European Commission impose fines directly on manufacturers?

Yes. Under Art. 85(1), the Commission may impose administrative fines of up to EUR 30,000 per non-compliant vehicle, system, component or separate technical unit when it takes corrective or restrictive measures under Art. 53. These fines are not cumulative with Member State penalties for the same infringement [Art. 85(1)].

What obligations do non-EU manufacturers have?

Non-EU manufacturers must appoint a single authorised representative established within the Union for both type-approval and market surveillance purposes [Art. 13(4)]. They remain fully responsible for all aspects of the approval procedure and conformity of production [Art. 13(1)].

Are independent repairers entitled to access vehicle repair data?

Yes. Art. 61(1) requires manufacturers to provide unrestricted, standardised and non-discriminatory access to vehicle OBD information, diagnostic tools, software downloads, and repair and maintenance information. Manufacturers must also provide a secure remote facility for operations involving vehicle security systems [Art. 61(1)].

What is the record retention period for type-approval documentation?

Manufacturers must keep EU type-approval certificates and attachments for 10 years after the end of validity of a vehicle type-approval, and 5 years for systems, components or separate technical units. Copies of certificates of conformity must be kept for 10 years from the date of vehicle manufacture [Art. 14(3)].

What qualifies as a manipulation device under this Regulation?

Art. 84(3a)(b) penalises manufacturers who design, construct and assemble vehicles with manipulation devices or strategies that cause a non-compliant vehicle to appear compliant. This provision was inserted by Regulation (EU) 2024/1257 and directly targets defeat-device scenarios.

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