Article 6 Verification procedure in case of a change to a subsystem

In the event of a change to a subsystem, the applicant shall analyse the change and assess the impact on the ‘EC’ declaration of verification.

Where the validity of an element of the relevant ‘EC’ declaration of verification is impacted by that change, the applicant shall update the ‘EC’ declaration of verification or shall establish a new ‘EC’ declaration of verification. A new ‘EC’ declaration of verification shall be established whenever a new authorisation according to criteria set out in Articles 18(6) and 21(12) of Directive (EU) 2016/797 is required.

Where a change affects a basic parameter, the applicant shall assess the need for, and where required carry out the ‘EC’ verification procedure set out in Article 15 of Directive (EU) 2016/797 and Annex IV to that Directive for the changed subsystem.