21L.B.201 Type-certification basis and applicable environmental protection requirements for a repair design approval

Regulation (EU) 2022/1358

The Agency shall designate any amendments to the type-certification basis and the applicable environmental requirements incorporated by reference in, as applicable, either the type certificate or the supplemental type certificate, which the Agency considers necessary for maintaining a level of safety and environmental compatibility equal to that previously established and notify them to the applicant for the approval of a repair design.

21L.B.202 Investigation and issuance of an approval for a minor repair design

Regulation (EU) 2022/1358

(a) Upon receiving an application for the approval of a minor repair design to a type-certified product under this Annex, the Agency shall approve the minor repair design when:

1. the applicant has provided the substantiation data and justifications and has demonstrated and declared the compliance of the repair design with the applicable type-certification basis and the applicable environmental protection requirements established in accordance with point 21L.B.201;

2. the Agency, through its verification of the demonstration of compliance, taking into account the design features of the repair design, complexity and overall criticality of the repair design, as well as previous experience of design activities with the applicant, has not found:

(i) any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements;

(ii) any feature or characteristic of the repair design that may make the product with the repair design unsafe for the uses for which certification is requested.

(b) An approval of a minor repair design shall be limited to the specific configuration(s) in the type certificate to which the repair design relates.

21L.B.203 Investigation of an application for the approval of a major repair design

Regulation (EU) 2022/1358

Upon receiving an application for the approval of a major repair design 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.201; 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 repair design with the type‑certification basis or with 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 configuration with the repair design is necessary in order to verify the compliance of the product with the applicable type-certification basis; the Agency shall notify the applicant before conducting this inspection and assessment;

(d) if, during the review of the compliance demonstration plan, the Agency determines that the major repair design contains any element for which an unidentified non-compliance with the type‑certification basis or with 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 investigation.

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

If EASA determines that there is a need to conduct a first-article inspection of the changed product under point 21L.B.203(c), then AMC2 21L.B.46(c) provides the description of this activity for EASA.

21L.B.204 Issuance of an approval of a major repair design

Regulation (EU) 2022/1358

(a) Upon receiving an application for the approval of a major repair design to a type-certified product under this Annex, the Agency shall approve the major repair design when:

1. the applicant has been demonstrated that the repair design and the areas affected by the repair design comply with the type-certification basis and with the applicable environmental protection requirements, as established by the Agency in accordance with point 21L.B.201; and

2. the applicant has demonstrated and declared compliance in accordance with point 21L.A.208;

3. the owner of the type-certificate data, if the applicant has specified in accordance with point 21L.A.205(b)(5) that they provided the certification dataon the basis of an arrangement with the owner of the type-certificate data, has:

(i) no technical objection to the information submitted under point (a)(2) of point 21L.B.204; and

(ii) agreed to collaborate with the holder of the repair design approval to discharge all the obligations for the continued airworthiness of the product with the repair design through compliance with point 21L.A.210;

4. the Agency, through its verification of the demonstration of compliance, has not found:

(i) any non-compliances with the type-certification basis or, where applicable, the applicable environmental protection requirements;

(ii) any feature or characteristic of the change that may make the product with the repair design unsafe for the uses for which certification is requested.

(b) An approval of a major repair design shall be limited to the specific configuration(s) in the type certificate to which the repair design relates.

21L.B.205 Continuing airworthiness oversight of products for which a repair design has been approved

Regulation (EU) 2022/1358

If the Agency, through its continuing airworthiness oversight, including through reports received in accordance with point 21L.A.3, or by any other means detects a non-compliance of a product, for which a repair design has been approved, with the type-certification basis or with the applicable environmental protection requirements, the Agency shall raise a finding in accordance with point 21L.B.21, or issue an airworthiness directive under the conditions of point 21L.B.23.

21L.B.206 Unrepaired damage

Regulation (EU) 2022/1358

An evaluation of the airworthiness consequences shall be conducted by the Agency, when requested to do under point 21L.A.211, in the event that a damaged product is left unrepaired and is not covered by previously approved data. The Agency shall establish any limitations necessary to ensure a safe flight with the damaged product.