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ORA.AeMC.115 Application

Regulation (EU) 2024/2076

Applicants for an AeMC certificate shall:

(a)     comply with MED.D.005; and

(b)     in addition to the documentation for the approval of an organisation required in ORA.GEN.115, provide details of clinical attachments to or liaison with designated hospitals or medical institutes for the purpose of specialist medical examinations.

[applicable until 12 February 2025 - Regulation (EU) 1178/2011]

(b)     in addition to the documentation for the approval of an organisation required in point ORA.GEN.115, provide details of activities that are contracted to designated hospitals or medical institutes for the purpose of specialist medical examinations.

[applicable from 13 February 2025 - Regulation (EU) 2024/2076]

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