21.B.100 Level of involvement

• Regulation (EU) 2019/897 found in: Initial Airworthiness and Environmental Protection (No 748/2012) Part-21 Part-21L (Jul 2024)

21.B.100 Level of involvement Regulation (EU) 2019/897 (a)     The Agency shall determine its involvement in the verification of the compliance demonstration activities and data related to the application for a type-certificate, restricted type-certificate, major change approval, supplemental type certificate, major repair design approval or ETSO authorisation for APU. It shall do so on the basis of an assessment of meaningful groups of compliance demonstration activities and data of the certification programme. That assessment shall address: — the likelihood of an unidentified non-compliance with the type-certification basis, operational suitability data certification basis or environmental protection requirements; and — the potential impact of that non-compliance on product safety or environmental protection, and consider at least the following elements: 1.       novel or unusual features of the certification project, including operational, organisational and knowledge management aspects; 2.       complexity of the design and/or demonstration of compliance; 3.       criticality of the design or technology and the related safety and environmental risks, including those identified on similar designs; and 4.       performance and experience of the design organisation of the applicant in the domain concerned. (b)     For the approval of a minor repair design, minor change or ETSO authorisation other than for APU, the Agency shall determine its involvement at the level of the entire certification project, taking into account any novel or unusual features, complexity of the design and/or demonstration of compliance, criticality of the design or technology, as well as the performance and experience of the applicant's design organisation. (c)      The Agency shall notify its level of involvement to the applicant and it shall update its level of involvement when this is warranted by information which has an appreciable impact on the risk previously assessed pursuant to point (a) or (b). The Agency shall notify the applicant about the change in the level of involvement.