Regulation
(EU) No 748/2012
(a) The holder of the ETSO
authorisation may make minor design changes (any change other than a major
change) without further authorisation by the Agency. In this case, the changed
article keeps the original model number (part number changes or amendments shall
be used to identify minor changes) and the holder shall forward to the Agency
any revised data that are necessary for compliance with point 21.A.603(b).
(b) Any design change by the
holder of the ETSO authorisation that is extensive enough to require a
substantially complete investigation to determine compliance with an ETSO
is a major change. Before making such a change, the holder shall assign a new
type or model designation to the article and apply for a new authorisation
under point 21.A.603.
(c) No design change by any
natural or legal person other than the holder of the ETSO authorisation who
submitted the statement of compliance for the article is eligible for approval
under this Subpart O unless the person seeking the approval applies under point 21.A.603 for a separate ETSO authorisation.