CAO.B.017 Means of compliance

(a)The Agency shall develop Acceptable Means of Compliance (‘AMC’) that may be used to demonstrate compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts.

(b)Alternative means of compliance may be used to demonstrate compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts

(c)The competent authority shall establish a system to consistently evaluate that all alternative means of compliance used by organisations under its oversight allow for the establishment of compliance with Regulation (EU) No 2018/1139 and its delegated and implementing acts.

(d)The competent authority shall evaluate all alternative means of compliance proposed by an organisation in accordance with point CAO.A.017 by analysing the documentation provided and, if considered necessary, conducting an inspection of the organisation. When the competent authority finds that the alternative means of compliance are in accordance with Regulation (EU) 2018/1139 and its delegated and implementing acts, it shall without undue delay:

(1)notify the applicant that the alternative means of compliance may be used and, if applicable, amend the approval or certificate of the applicant accordingly;

(2)notify the Agency of their content, including copies of all relevant documentation.