Commission Implementing Regulation (EU) 2018/545Show full title

ANNEX III Aspects for assessment by the concerned NSAs for the area of use

This Annex is not applicable when the area of use covers the whole EU network and the TSIs contain specific conditions for this.

The information that shall be assessed by the concerned NSAs for the area of use in relation to the relevant national rules is specified per authorisation case. An (x) in the column for the applicable authorisation case indicates that this aspect is mandatory to assess for this authorisation case

		First authorisation	New authorisation	Extended area of use	Renewed type authorisation
1	Application consistent with the pre-engagement baseline (when applicable)	X	X	X	X
2	The area of use for the concerned Member State is correctly specified	X	X	X	X
3	The national rules and requirements for the concerned area of use identified by the applicant are correct.	X	X	X
4	Selected conformity assessment bodies relevant for the concerned area of use (designated body(ies), assessment body (CSM RA)) have the proper accreditation or recognition as applicable.	X	X	X	X
5	Sufficient evidence from the methodology used for the requirements capture only for the national rules for the concerned area of use: 5.1. When another methodology than the risk management process set out in Annex I of Regulation (EU) No 402/2013, has been used as the methodology for requirements capture the following shall be checked: (a) System definition is complete and consistent with the design of the vehicle? (b) Hazard identification and classification is consistent and plausible? (c) All risks have been properly managed and mitigated? (d) Requirements derived from the risk management are properly traced to the risk and to the evidence of compliance with the requirement?	X	X	X
6	EC Declarations of Verification and Certificates (national rules) (Article 15 Directive (EU) 2016/797), check: 6.1. Signatures 6.2. Validity 6.3. Scope 6.4. Conditions for use of the vehicle, other restrictions, non-compliances	X	X	X	X
7	Reports from conformity assessment bodies (Article 15 Directive (EU) 2016/797), check: 7.1. Consistency with EC Declarations of Verification and certificates. 7.2. Deviations & non-conformities (when applicable) are identified 7.3. Conditions for use and other restrictions are properly identified and are consistent with the conditions in the application for authorisation. 7.4. The supporting evidences used by conformity assessment bodies are matching the applicable assessment phases described in national rules.	X	X	X	X
8	Existing conditions for use of the vehicle and other restrictions		X	X	X
9	CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems positive opinion.	X	X	X
10	CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle (significant change) positive opinion		X	X
11	Changes as compared to the authorised vehicle type are sufficiently described and match the CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013)		X
12	EC Declarations of Verification and EC certificates are properly updated in relation to the changed/updated national rules				X
13	Reports from conformity assessment bodies are properly updated in relation to the changed/updated rules: 13.1. Changed/updated national rules are covered 13.2. There is evidence that the vehicle type still fulfils the requirements				X