The facilities where the clinical investigation is to be conducted shall be suitable for the clinical investigation and shall be similar to the facilities where the device is intended to be used.
Beidh na saoráidí ina ndéanfar an t-imscrúdú cliniciúil oiriúnach don imscrúdú cliniciúil agus beidh siad cosúil le saoráidí inar beartaíodh an fheiste a úsáid.