AMC3 ARA.FSTD.120 Continuation of an FSTD qualification
ED Decision 2025/002/R
EXTENDED EVALUATION PERIOD — GENERAL
(a) The competent authority should determine the length of the extended recurrent evaluation period of an FSTD, taking into consideration the information listed in point (a) of AMC2 ORA.FSTD.225(b). The extended evaluation period should be 24 or 36 months.
(b) The extension of the recurrent evaluation period should be driven by a risk-based approach as part of the continuous oversight. As such, the performance of the organisation, as well as the performance of the device, should be monitored.
(c) Once the competent authority has granted an extended recurrent evaluation period, it may plan all subsequent recurrent evaluations of the relevant FSTD with the extended time interval of 24 or 36 months, as applicable, until it decides to revert again to a shorter recurrent evaluation period, should the conditions of point ARA.FSTD.120(c) be no longer fulfilled.
(d) The audit of the management system elements, described in point ARA.FSTD.120(c)(3), may be performed remotely, at the discretion of the competent authority, considering the performance of the organisation.
