EU implementing regulation on type-approval of the automated driving system (ADS) of fully automated vehicles

The relevant entries of the information document submitted with the type-approval application under Article 24(1)(a) of Regulation (EU) 2018/858 must consist of the information for the ADS set out in Annex I. In practice this means describing, in a format the authority can check, the ODD boundaries, system architecture, perception and decision chain, degradation strategy, remote assistance interface and dual-mode transition conditions.

Applies when

Manufacturers seeking ADS type approval and their EU representatives.

Evidence to retain

• · ADS information document structured to the Annex I entries
• · ODD boundary definition and exit condition description
• · System architecture diagram and inventory of safety-relevant interfaces
• · For dual mode vehicles, design and test evidence that mode transitions occur only at standstill

Estimated first-time effort: 15–40 person-days (estimate, not a commitment)

ADS type approval is subject to the Annex II technical specifications, assessed by the approval authority or its technical service in accordance with Annex III; as amended by Implementing Regulation (EU) 2026/481, Article 3(2) adds a second subparagraph subjecting the type approval of automated valet parking (AVP) features to the Annex V technical specifications, assessed under Annex V. The overall Annex III compliance assessment consists of five parts: the traffic scenarios to consider; assessment of the ADS safety concept and audit of the manufacturer safety management system; tests for the most relevant traffic scenarios; credibility assessment principles for a virtual toolchain used in ADS validation; and the system established by the manufacturer to ensure in-service reporting. Any Annex II requirement may be checked by tests performed by the approval authority or its technical service. Scenarios and parameters must be used where relevant to the ADS ODD; where the manufacturer deviates from the proposed parameters, the safety performance metrics and inherent assumptions used must be documented in the documentation package and shown to be adequate.

Applies when

Manufacturers and their ADS suppliers; teams relying heavily on virtual validation must prepare dedicated toolchain credibility evidence.

Evidence to retain

• · Scenario catalogue with ODD relevance justification, including safety performance metrics and assumptions where proposed parameters are not followed
• · ADS safety concept document and safety management system audit records
• · Physical test plan and test reports for the most relevant scenarios
• · Credibility assessment report for the virtual simulation toolchain (model verification, validation and uncertainty analysis)
• · Technical service findings list and closure records

Estimated first-time effort: 80–240 person-days (estimate, not a commitment)

The Regulation separates two concepts: in-service monitoring means data collected by the manufacturer and data from other sources to obtain evidence on the in-service safety performance of the ADS in the field; in-service reporting means data reported by the manufacturer to demonstrate that safety performance. Part 5 of Annex III makes the system established by the manufacturer to ensure in-service reporting part of the compliance assessment, so it must be auditable at type approval rather than built after launch.

Applies when

Manufacturers and transport service operators; where data returns from the EU to China for analysis, cross-border transfer compliance must be handled in parallel.

Evidence to retain

• · Inventory of in-service monitoring data items, their sources and collection methods
• · Design document for the in-service reporting system (content, frequency, accountable owner)
• · Data quality control and anomaly detection procedures
• · Data provision and responsibility allocation agreement with the transport service operator
• · Legal assessment record for cross-border data transfers

Estimated first-time effort: 20–60 person-days (estimate, not a commitment)