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21L.B.46 Investigation

Annex Ib · Regulation (EU) No 748/2012 · EAR revision 27 Nov 2025

IRImplementing rule

21L.B.46Investigation

Upon receiving an application for a type certificate under this Annex, the Agency shall:

(a)conduct a review of the initial compliance demonstration plan and any subsequent update provided by the applicant in order to establish the completeness of the plan and the appropriateness of the proposed means and methods of demonstrating compliance with the type-certification basis established in accordance with point 21L.B.43 and with the applicable environmental protection requirements designated in accordance with point 21L.B.45; if the compliance demonstration plan is incomplete or the means and methods are not appropriate to achieve compliance demonstration, the Agency shall inform the applicant and request an amendment of it;

(b)when satisfied that the compliance demonstration plan provided is appropriate so that the applicant can demonstrate compliance, approve the compliance demonstration plan and any subsequent updates of the compliance demonstration plan;

(c)after receiving the declaration of compliance in accordance with point (f) of point 21L.A.25, conduct a physical inspection and assessment of the first article of that product in the final configuration, taking into consideration the critical design review carried out in accordance with point (a) of point 21L.B.242, in order to verify the compliance of the product with the applicable type-certification basis and the applicable environmental protection requirements; the Agency shall verify the compliance of the product, considering the likelihood of an unidentified non-compliance with the type-certification basis or the applicable environmental protection requirements, and the potential impact of that non-compliance on the safety or environmental compatibility of the product;

(d)if during the establishment of the type-certification basis, designation of the applicable environmental protection requirements or during the review of the compliance demonstration plan the Agency determines that the product design contains any element for which an unidentified non-compliance with the type-certification basis or the applicable environmental protection requirements may have an adverse impact on the safety or environmental compatibility of the product, the Agency shall determine which investigations are necessary in addition to those described in point (c) in order to verify the compliance demonstration; the Agency shall notify the applicant of any additional investigations and which elements of the design would be subject to those investigations.

IR · 21L.B.46 — Regulation (EU) No 748/2012 · Regulation (EU) 2022/1358 · Initial Airworthiness Easy Access Rules · EAR revision 27 Nov 2025

AMCAcceptable means of compliance

AMC1 21L.B.46(c)Investigation

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PHYSICAL INSPECTION AND CRITICAL DESIGN REVIEW Prior to the approval of the flight conditions to support the issuance of a permit to fly, a physical inspection and a critical design review is conducted with the applicant and the competent authority for conformity (production) under point 21L.B.242(a). The experience and outcome of this activity should be used by EASA to determine the scope and particular aspects of the design that should be the focus of the physical inspection and assessment of the first article of that product (first-article inspection) that is conducted under point 21L.B.46(c) prior to the issuance of the type certificate for a particular product.

AMC · AMC1 21L.B.46(c) — Regulation (EU) No 748/2012 · ED Decision 2023/013/R · Initial Airworthiness Easy Access Rules · EAR revision 27 Nov 2025

AMCAcceptable means of compliance

AMC2 21L.B.46(c)Investigation

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PHYSICAL INSPECTION AND ASSESSMENT OF THE FIRST ARTICLE OF A PRODUCT (FIRST-ARTICLE INSPECTION)

1.Purpose The purposes of the first-article inspection (of the article that is in conformance with the proposed type design for certification) prior to the issuance of the type certificate for a particular aircraft, propeller or engine design are: a. for EASA to verify the completion of the demonstration-of-compliance activities conducted by the applicant under point 21L.A.25 and in accordance with the approved compliance-demonstration plan; b. for EASA to verify with a risk-based approach that the type design complies with the type-certification basis and the applicable environmental protection requirements; c. in case the applicant is a declared design organisation, for EASA to conduct a further oversight visit in accordance with point 21L.B.183(b) of Subpart J in order to ensure that the applicant is able to discharge its obligations.

2.Methodology and evidence The first-article inspection should be conducted by EASA at an appropriate location(s) selected by the applicant for a type certificate. This (these) location(s) should include the physical location of the aircraft, engine or propeller for which the type certificate has been requested and should be in the principal place of business (which in accordance with Article 8(2) of Regulation (EU) No 748/2012 must be in an EU Member State). The Agency should conduct a physical inspection of the aircraft, engine or propeller for which the type certificate has been requested. This inspection, along any other activity that is considered necessary should ensure that the objectives mentioned in point 1 are met. Evidence to support compliance will be gathered by EASA prior to and during the first-article inspection. The physical inspection of the aircraft and, if applicable, of the engine and the propeller will provide substantial evidence that the design is in compliance with the type-certification basis and that the applicant (if a declared design organisation) is able to discharge its obligations. Additional sources of evidence to support the determination of compliance of the design that are available to EASA prior to and during the first-article inspection include: a. witnessing or participating in live testing (including flight testing) of the aircraft, engine, propeller, systems or components; b. evaluation of the final compliance-demonstration plan produced by the applicant and how it relates to the final design; c. evaluation of the completeness of the declaration of compliance submitted by the applicant; d. evaluation of supporting compliance documentation and test reports; e. discussions with key design and production personnel; f. review of design processes and procedures (for non-approved organisations). If the applicant selects to use flight testing to demonstrate compliance (see MC6 in Appendix A to AMC1 21L.A.24(b)), EASA may decide to conduct flight testing to verify compliance for applications for an aircraft type certificate. An appropriate flight-test plan should be developed and proposed by the applicant prior to the first-article inspection and agreed by EASA in order to ensure that there are no adverse flight characteristics. Flight testing could be a combination of: a. a predefined flight-test plan that is not specific to the particular aircraft type; b. specific flight testing to focus on targeted aspects after a review of the applicant’s flight-testing data/reports. The above list of additional sources of evidence is not exhaustive. It is possible that during the first-article inspection EASA may discover evidence that: a. the design is not in compliance with the type-certification basis or the applicable environmental protection requirements (this could be due to the applicant misinterpreting or misunderstanding the applicable design requirements); b. the applicant has not fulfilled its design obligations as a declared design organisation; c. there are shortfalls in the applicant’s design management system (in accordance with point 21.A.239 or 21L.A.174) that result in a non-compliance or a loss of control of the design. If such evidence is discovered, EASA may require a more in-depth investigation into the compliance documentation and/or the design practices of the design organisation. The purpose of this in-depth investigation should be to determine whether or not compliance was demonstrated, the root cause(s) and to establish corrective actions. This investigation should also serve to prevent a reoccurrence of the issue.

3.Aircraft condition and configuration The aircraft, engine or propeller presented to EASA should be in the final configuration for which a type certificate has been requested and the compliance demonstration has been declared. The applicant could arrange visits with EASA prior to the declaration of compliance (in accordance with point 21L.A.25(f)) (for example, for noise testing). Any differences between the configuration presented to EASA for the first-article inspection and the final configuration in the declaration of compliance (in accordance with point 21L.A.25(f)) should be justified by the applicant and should be subject to detailed scrutiny during the first-article inspection.

4.Availability of supporting documentation and key personnel The supporting documentation and compliance data should be available at the time EASA visits the applicant’s facilities or at any other time upon request by EASA. Key design personnel will be made available to EASA in case of need. If this is not the case, EASA might not be in a position to issue the type certificate.

5.Findings and resolution If a non-compliance is discovered by EASA in the process of the activities mentioned in point 2, an appropriate finding or observation should be raised against the aircraft, engine or propeller or declared design organisation in accordance with point 21L.B.21, which may result in the enforcement measures contained in point 21L.B.22. Findings of non-compliance should be resolved before the type certificate is issued. Depending upon their nature, findings against the declared design organisation may need to be resolved before the type certificate is issued.

AMC · AMC2 21L.B.46(c) — Regulation (EU) No 748/2012 · ED Decision 2023/013/R · Initial Airworthiness Easy Access Rules · EAR revision 27 Nov 2025

All rules in SECTION B - PROCEDURES FOR COMPETENT AUTHORITIES

Consolidated from the EASA Easy Access Rules (revision 27 Nov 2025, extracted 17 Aug 2026) for convenience. Not the official publication — verify against the Official Journal of the European Union and the EASA publications before operational use.

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