The Medical Devices Regulations 1994

Fees

21.—(1) A notified body may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with, performing a function required by or under any of the Annexes referred to in regulations 7, 8, 9, 10 and 11 to be performed by a notified body.

(2) Except as provided 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 notified body is a body the activities of which are carried on for profit, the fee for doing anything 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 notified body may require payment of a 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.