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21L.B.102 Investigation

Regulation (EU) 2022/1358

Upon receiving an application for a supplemental 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 and the applicable environmental protection requirements established and designated in accordance with point 21L.B.101; 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)      determine the likelihood of an unidentified non-compliance of the major change 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, and determine on that basis whether a physical inspection and assessment of the first article of that product in the final changed configuration is necessary in order to verify the compliance of the product with the applicable type-certification basis and the applicable environmental protection requirements, taking into consideration the critical design review if carried out in accordance with point (a) of point 21L.B.242; the Agency shall notify the applicant before conducting this inspection and assessment;

(d)     if during the establishment of the type-certification basis, the designation of the applicable environmental protection requirements or during the review of the compliance demonstration plan, the Agency determines that the major change to the 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 changed product, the Agency shall determine which investigations are necessary in addition to those of point (c) in order to verify the compliance demonstration; the Agency shall notify the applicant of those additional investigations and which elements of the design would be subject to this investigation.