Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.
I gcás inarb iomchuí, beidh na saoráidí ina ndéanfar an staidéar feidhmíochta, ina mbeidh ábhar páirteach, oiriúnach don staidéar feidhmíochta agus beidh siad cosúil leis na saoráidí ina mbeartaítear an fheiste a úsáid.