The Medical Devices Fees Regulations 1995

Regulation 3

SCHEDULE TABLE OF FEES

Column 1	Column 2	Column 3
Fee No.	Matter	Fee
1(a)	notice in respect of a (i) Group A device (ii) Group B device except where fee 1(b) is payable	(i) £900 (ii) £3,000
1(b)	second or subsequent notice in respect of a device given only to address the grounds for any notice by the Secretary of State under regulation 7(2) of the 1992 Regulations or regulation 16(2) of the 1994 Regulations that the device in question should not be made available for purposes of clinical investigation being a notice in respect of a (i) Group A device (ii) Group B device	(i) £650 (ii) £2,100
2(a)	application for designation except where fee 2(b) is payable	£1,300
2(b)	second or subsequent application for designation made only to address the grounds for rejection of a previous application	£400
2(c)	request by a body for a material extension to be made to the scope of the tasks in respect of which it has applied to be designated	£1,300
2(d)	request by a notified body for a material extension to be made to the scope of the tasks which it is designated by the Secretary of State to carry out	£1,300
2(e)	inspection of premises pursuant to regulation 8(7)(a) of the 1992 Regulations or regulation 17(7)(a) of the 1994 Regulations being an inspection for the purpose of deciding whether or not a body is one in respect of which the conditions specified in Annex 8 of the 1990 Directive or Annex XI of the 1993 Directive (i) are fulfilled as respects the tasks which it is to carry out	(i)  £2,700 plus— (a) time spent by a member of staff out of the office while undertaking a site visit (to include time spent travelling or staying overnight) at the rate of 160 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, (b) actual costs of travel, accommodation and subsistence, and (c) out of pocket expenses
	(ii) continue to be fulfilled as respects the tasks which it carries out	(ii)  £1,600 plus— (a) time spent by a member of staff out of the office while undertaking a site visit (to include time spent travelling or staying overnight) at the rate of 160 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, (b) actual costs of travel, accommodation and subsistence, and (c) out of pocket expenses
2(f)	inspection of premises pursuant to regulation 8(7)(b) of the 1992 Regulations or regulation 17(7)(b) of the 1994 Regulations	£1,600 plus— time spent by a member of staff out of the office while undertaking a site visit (to include time spent travelling or staying overnight) at the rate of 160 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, actual costs of travel, accommodation and subsistence, and out of pocket expenses