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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 reg 49

reg 49 Fees charged by approved bodies and conformity assessment bodies

(1) An approved body or CAB 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 an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; and (b) in the case of a CAB , performing the functions of a CAB arising out of a mutual recognition agreement in respect of a conformity assessment procedure for a medical device. (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 approved 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 approved body ; and (b) the commercial rate normally charged in respect of profit for that work or similar work. (4) The approved 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.

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