Regulation 16 Clinical investigation fees

(1)

The sponsor of a clinical investigation must pay the relevant fee for—

(a)

an application submitted to the Secretary of State under Article 70(1);

(b)

a notification to the Secretary of State of a substantial modification under Article 75(1).

(2)

The relevant fee is payable when the application or notification to which it relates is made to the Secretary of State.

(3)

If a sponsor fails to pay the relevant fee, the Secretary of State may reject the application, reject the notification or suspend the clinical investigation until the fee is paid.

(4)

Fees for clinical investigations are set out in Schedule 1.

(5)

In this regulation, “the relevant fee” means—

(a)

for a clinical investigation of a class I device, class IIa device or non-invasive class IIb device, the fee in table 1 in Schedule 1, and

(b)

for a clinical investigation of an invasive class IIb device or class III device, the fee in table 2 in Schedule 1.