The Medical Devices (Consultation Requirements) (Fees) Regulations 1995

Fees

3.—(1) Subject to regulation 2(2) and the following paragraphs of this regulation, in respect of a consultation in relation to a medical device which incorporates a medicinal substance manufactured by—

(a) an approved manufacturer of that substance, the fee shall be £2,500;

(b) any other manufacturer, the fee shall be £7,000.

(2) Subject to the following paragraphs of this regulation, in respect of a further consultation in relation to a medical device which incorporates a medicinal substance manufactured by—

(a) an approved manufacturer of that substance, the fee shall be £625;

(b) any other manufacturer, the fee shall be £1,750.

(3) Subject to regulation 2(2) and the following paragraphs of this regulation, in respect of a consultation in relation to a medical device which incorporates more than one medicinal substance,—

(a) if each medicinal substance is manufactured by an approved manufacturer of that substance, the fee shall be £2,500;

(b) if any of those medicinal substances is not manufactured by an approved manufacturer of that substance, the fee shall be £7,000.

(4) Subject to the following paragraphs of this regulation, in respect of a further consultation in relation to a medical device which incorporates more than one medicinal substance,—

(a) if each medicinal substance is manufactured by an approved manufacturer of that substance, the fee shall be £625;

(b) if any of those medicinal substances is not manufactured by an approved manufacturer of that substance, the fee shall be £1,750.

(5) Subject to paragraph (6), in respect of a consultation in relation to a medical device which incorporates any new medicinal substance—

(a) where the competent body has not previously been consulted in relation to a medical device which incorporates that substance, the fee shall be £32,000;

(b) where it has previously been so consulted, the fee shall be £8,000.

(6) Subject to regulation 2(2), where the same notified body consults the competent body on the same occasion in relation to a number of devices which—

(a) are of similar construction and are designed to perform similar functions;

(b) incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

(c) do not incorporate any other medicinal substance;

the amount of the fee in respect of that consultation shall be equal to the amount of the fee which would, but for this paragraph, be payable under the preceding paragraphs of this regulation for a consultation in relation to one of those devices. Payment and recovery of fees