The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the clinical investigation is conducted.
Bainfidh an t-urraitheoir agus an t-imscrúdaitheoir leas as an gcóras dá dtagraítear i mír 1 san fhoirm is iomchuí don Bhallstát ina ndéantar an t-imscrúdú.