21L.B.81 Type-certification basis and applicable environmental protection requirements for a major change to a type certificate
Regulation (EU) 2022/1358
(a) The Agency shall establish the type-certification basis for a major change to a type certificate and notify it to the applicant.
(b) For a major change to a type certificate and the areas affected by the change, the type-certification basis shall consist of the certification specifications incorporated by reference in the type certificate, unless:
1. the Agency finds that the certification specifications referenced in the type certificate do not provide adequate standards with respect to the proposed change, therefore the change and the areas affected by the change shall also comply with any special conditions, and amendments to those special conditions, prescribed by the Agency in accordance with point 21L.B.44, to provide a level of safety equivalent to that established by the certification specifications applicable on the date of the application for the change;
2. an applicant chooses to comply with a certification specification set out in an amendment that is applicable on the date of the application for the change.
(c) The Agency shall designate the applicable environmental protection requirements for the major change to a type certificate in accordance with point 21.B.85 of Annex I (Part 21) and notify them to the applicant.
21L.B.82 Investigation and issuance of an approval of a minor change to a type certificate
Regulation (EU) 2022/1358
(a) Upon receiving an application for the approval of a minor change to a type certificate under this Annex, the Agency shall approve the minor change when:
1. the applicant has provided the substantiation data and justifications, and has demonstrated and declared the compliance of the change with the applicable type-certification basis and the applicable environmental protection requirements, or with the certification specifications chosen in accordance with point 21L.A.67;
2. the Agency, through its verification of the demonstration of compliance, taking into account the design features, complexity and overall criticality of the design or technology, 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, or with the certification specifications chosen;
(ii) any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.
(b) An approval of a minor change to a type certificate shall be limited to the specific configuration(s) in the type certificate to which the change relates.
21L.B.83 Investigation of a major change to a type certificate
Regulation (EU) 2022/1358
Upon receiving an application for a major change to 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 and the applicable environmental protection requirements established and designated in accordance with point 21L.B.81; 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 also approve 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 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 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)(3) 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 design of the major change 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 investigation.
AMC1 21L.B.83(c) Investigation of a major change to a type certificate
ED Decision 2023/013/R
PHYSICAL INSPECTION AND CRITICAL DESIGN REVIEW
Depending upon the nature of the design change, 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 should be 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 need for a physical inspection and assessment of the first article of that changed product (first-article inspection) that may be conducted under point 21L.B.83(d) prior to the issuance of the supplemental type certificate for the change.
AMC1 21L.B.83(d) Investigation of a major change to a type certificate
ED Decision 2023/013/R
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.83(c), then AMC2 21L.B.46(c) provides the description of this activity for EASA.
21L.B.84 Issuance of an approval of a major change to a type certificate
Regulation (EU) 2022/1358
(a) The Agency shall approve the major change when:
1. the applicant has demonstrated that the change and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established and designated by the Agency in accordance with point 21L.B.81;
2. the applicant has demonstrated and declared compliance in accordance with point (f) of point 21L.A.66;
3. 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, with the applicable environmental protection requirements;
(ii) any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.
(b) An approval of a major change to a type certificate shall be limited to the specific configuration(s) in the type certificate to which the change relates.
21L.B.85 Continuing airworthiness oversight of changed products for which a type certificate has been issued
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 with the type-certification basis or the applicable environmental protection requirements of a product for which a change to a type certificate has been approved, 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.