PART VF1Notified Bodies F1Approved Bodies, Conformity Assessment Bodies and Marking of Products
F2Fees charged by approved bodies and conformity assessment bodies49.
(1)
F3An approved body or CAB may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—
F4(a)
in the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; and
(2)
Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.
(3)
Where the F7approved body or CAB charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—
(a)
the character and extent of the work done or to be done by the F8approved body; and
(b)
the commercial rate normally charged in respect of profit for that work or similar work.
(4)
The F9approved body or CAB may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.
F10Fees charged by UK notified bodies and conformity assessment bodies49.
(1)
A UK notified body or F11CAB may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—
(a)
in the case of a UK notified body, performing the functions of a notified body or an importing Party under F12the Medical Devices Directives or a UK mutual recognition agreement in respect of a conformity assessment procedure set out in the Medical Devices Directives or these Regulations as they apply in Great Britain; and
(2)
Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.
(3)
Where the UK notified body or F15CAB charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—
(a)
the character and extent of the work done or to be done by the notified body; and
(b)
the commercial rate normally charged in respect of profit for that work or similar work.
(4)
The UK notified body or F16CAB may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.