PART VIFees charged by the Secretary of State
Interpretation of Part VI52
1
In this PartF24...—
“Group A device” means a Class I medical device, a Class IIa medical device, or a Class IIb medical device which is neither an implantable device nor a long term invasive medical device;
“Group B device” means a Class IIb medical device which is either an implantable medical device or a long term invasive medical device, or a Class III medical device, or an active implantable medical device; and “half day” means a period of three and a half hours.
2
For the purposes of this Part, medical devices are classified as being implantable or long term invasive medical devices in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42, and in the event of a dispute over the classification of a device, the Secretary of State shall determine the classification of the device in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42.
Fees in connection with the registration of devices and changes to registration detailsE153
Any person required to supply the Secretary of State with any information under F33regulation 7A, 19, 21A, 33A or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of F58£100, and that fee—
a
shall be payable when the information is supplied by that person to the Secretary of State; and
b
shall accompany that information when it is supplied.
Fees in connection with the registration of devices and changes to registration detailsE353
Any person required to supply the Secretary of State with any information under regulation 19 F39, 21B or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of F104£100, and that fee—
a
shall be payable when the information is supplied by that person to the Secretary of State; and
b
shall accompany that information when it is supplied.
F25Fees payable in connection with the designation of approved bodiesE854
1
A corporate or other body that applies to the Secretary of State for designation under regulation 45 as F22an approved body shall, in connection with that application for designation, pay to the Secretary of State—
a
if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F47£2,063; or
b
in all other cases, a fee of F49£8,252.
2
A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of F34£6,504.
3
Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F4both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of F45a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—
F50a
in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of F41£15,904 plus the amounts specified in paragraph (3A);
b
in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection—
i
if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in all three of the Annexes referred to in this paragraph are met, a fee of F63£10,160,
ii
if the inspection is for the purpose of deciding whether or not the body is one in respect of which the criteria set out in only two of the three Annexes referred to in this paragraph are met, a fee of F63£10,160, or
iii
if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in only one of the Annexes referred to in this paragraph are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of F45a mutual recognition agreement which it needs to be able to fulfil, a fee of F63£10,160,
plus the amounts specified in paragraph (3A); and
c
in respect of an inspection pursuant to regulation 45(7)(b), a fee of F40£4,404 plus the amounts specified in paragraph (3A).
F23A
Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—
a
an amount for time spent by a member of staff undertaking a site visit at a rate—
i
for the time spent on site, of F23£361.20 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, and
ii
for the time spent travelling to and from the site, of F44£90.30 per hour;
b
the actual costs of travel, accommodation and subsistence; and
c
out of pocket expenses.
3B
Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—
a
the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and
b
the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).
F523C
F26An approved body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—
a
a fee of £8,252 in respect of the application; and
b
where an audit is carried out in connection with the application, a fee of £15,904 in respect of the audit.
3D
Where the Secretary of State conducts an assessment of F35an approved body pursuant to article 5 of Regulation (EU) No 920/2013, F59the approved body shall pay to the Secretary of State—
a
if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £2,586; or
b
in any other case, a fee of £3,876.
3E
F42An approved body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £532.
4
A fee under this regulation—
a
in connection with an application for designation under F29regulation 45(1), a variation under regulation 45(4)F28, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012—
i
shall be payable when the application F3or submission to the Secretary of State is made, and
ii
shall accompany the application F57or submission when it is made;
b
in connection with an inspection pursuant to regulation 45(7) F18or an audit or assessment pursuant to Regulation (EU) No 920/2013, shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.
F85
In this regulation, “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices F56(as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act).
Fees payable in connection with the designation etc. of UK notified bodiesE454
1
A corporate or other body that applies to the Secretary of State for designation under regulation 45 as a notified body shall, in connection with that application for designation, pay to the Secretary of State—
a
if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F82£2,063; or
b
in all other cases, a fee of F90£8,252.
2
A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of F70£6,504.
3
Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F72both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the body shall pay to the Secretary of State—
F83a
in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of F96£15,904 plus the amounts specified in paragraph (3A);
b
in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection—
i
if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in all three of the Annexes referred to in this paragraph are met, a fee of F98£10,160,
ii
if the inspection is for the purpose of deciding whether or not the body is one in respect of which the criteria set out in only two of the three Annexes referred to in this paragraph are met, a fee of F98£10,160, or
iii
if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in only one of the Annexes referred to in this paragraph are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, a fee of F98£10,160,
plus the amounts specified in paragraph (3A); and
c
in respect of an inspection pursuant to regulation 45(7)(b), a fee of F79£4,404 plus the amounts specified in paragraph (3A).
F743A
Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—
a
an amount for time spent by a member of staff undertaking a site visit at a rate—
i
for the time spent on site, of F88£361.20 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, and
ii
for the time spent travelling to and from the site, of F94£90.30 per hour;
b
the actual costs of travel, accommodation and subsistence; and
c
out of pocket expenses.
3B
Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—
a
the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and
b
the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).
F713C
A UK notified body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—
a
a fee of £8,252 in respect of the application; and
b
where an audit is carried out in connection with the application, a fee of £15,904 in respect of the audit.
3D
Where the Secretary of State conducts an assessment of a UK notified body pursuant to article 5 of Regulation (EU) No 920/2013, the UK notified body shall pay to the Secretary of State—
a
if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £2,586; or
b
in any other case, a fee of £3,876.
3E
A UK notified body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £532.
4
A fee under this regulation—
a
in connection with an application for designation under F92regulation 45(1), a variation under regulation 45(4)F100, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012—
i
shall be payable when the application F84or submission to the Secretary of State is made, and
ii
shall accompany the application F102or submission when it is made;
b
in connection with an inspection pursuant to regulation 45(7) F99or an audit or assessment pursuant to Regulation (EU) No 920/2013, shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.
F805
In this regulation, “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.
Fees payable in connection with the designation etc. of F10... conformity assessment bodiesE555
1
A corporate or other body that applies to the Secretary of State for designation under regulation 48 as F36a CAB shall, in connection with that application for designation, pay to the Secretary of State—
a
if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F60£2,063; or
b
in all other cases, a fee of F13£8,252.
2
A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of F62£6,504.
3
F27Subject to paragraphs (3A) to (3C) where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of F64a CAB arising out of F15a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—
F61a
in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of F38£15,904 plus the amounts specified in paragraph (3D);
b
in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of F14£4,404 plus the amounts specified in paragraph (3D);
c
in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of F20£1,880;
d
in respect of an inspection pursuant to regulation 48(7)(b), a fee of F1£4,404 plus the amounts specified in paragraph (3D).
F463A
Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be F21£15,904 plus—
a
F12£1,880 for each additional inspection; and
b
the amounts specified in paragraph (3D).
3B
Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be F53£4,404 plus—
a
F5£1,880 for each additional inspection; and
b
the amounts specified in paragraph (3D)
3C
Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be F48£1,880 for each inspection.
3D
The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—
a
an amount for time spent by a member of staff undertaking a site visit at a rate—
i
for the time spent on site, of F6£361.20 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, and
ii
for the time spent travelling to and from the site, of F16£90.30 per hour;
b
the actual costs of travel, accommodation and subsistence, and
c
out of pocket expenses.
4
A fee under this regulation—
a
in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—
i
shall be payable when the application to the Secretary of State is made, and
ii
shall accompany the application when it is made;
b
in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.
Fees payable in connection with the designation etc. of F31... conformity assessment bodiesE755
1
A corporate or other body that applies to the Secretary of State for designation under regulation 48 as F11a CAB shall, in connection with that application for designation, pay to the Secretary of State—
a
if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of F78£2,063; or
b
in all other cases, a fee of F101£8,252.
2
A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of F75£6,504.
3
F89Subject to paragraphs (3A) to (3C) where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of F7a CAB arising out of F30a UK mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—
F93a
in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of F69£15,904 plus the amounts specified in paragraph (3D);
b
in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of F85£4,404 plus the amounts specified in paragraph (3D);
c
in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of F73£1,880;
d
in respect of an inspection pursuant to regulation 48(7)(b), a fee of F77£4,404 plus the amounts specified in paragraph (3D).
F813A
Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be F86£15,904 plus—
a
F76£1,880 for each additional inspection; and
b
the amounts specified in paragraph (3D).
3B
Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be F87£4,404 plus—
a
F103£1,880 for each additional inspection; and
b
the amounts specified in paragraph (3D)
3C
Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be F68£1,880 for each inspection.
3D
The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—
a
an amount for time spent by a member of staff undertaking a site visit at a rate—
i
for the time spent on site, of F65£361.20 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, and
ii
for the time spent travelling to and from the site, of F66£90.30 per hour;
b
the actual costs of travel, accommodation and subsistence, and
c
out of pocket expenses.
4
A fee under this regulation—
a
in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—
i
shall be payable when the application to the Secretary of State is made, and
ii
shall accompany the application when it is made;
b
in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.
Fees payable in relation to clinical investigation noticesE656
1
Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—
a
if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—
i
a fee, if the device is a Group A device, of F9£2,920, or
ii
a fee, if the device is a Group B device, of F9£3,570; or
2
Except where paragraph (3) F17or (3A) applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or F32their UK responsible person has previously given such notice in relation to that device.
3
A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—
a
a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;
b
a change to the number of patients or devices forming the basis of the proposed trial;
c
a change or extension in the indications for use of the device or to the purpose or objectives of the trial;
d
a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or
e
a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.
F193A
Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—
a
a fee, if the device is a Group A device, of £207; or
b
a fee, if the device is a Group B device, of £331.
4
A fee under this regulation—
a
shall be payable when the notice to which it relates is given to the Secretary of State; and
b
shall accompany that notice when it is given.
Fees payable in relation to clinical investigation noticesE256
1
Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—
a
if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—
i
a fee, if the device is a Group A device, of F91£2,920, or
ii
a fee, if the device is a Group B device, of F91£3,570; or
2
Except where paragraph (3) F95or (3A) applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or his authorised representative has previously given such notice in relation to that device.
3
A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—
a
a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;
b
a change to the number of patients or devices forming the basis of the proposed trial;
c
a change or extension in the indications for use of the device or to the purpose or objectives of the trial;
d
a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or
e
a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.
F973A
Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—
a
a fee, if the device is a Group A device, of £207; or
b
a fee, if the device is a Group B device, of £331.
4
A fee under this regulation—
a
shall be payable when the notice to which it relates is given to the Secretary of State; and
b
shall accompany that notice when it is given.
F51Fees in connection with approval of coronavirus test devices56A
1
A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of—
a
£14,000; or
b
if the person is a small or medium-sized enterprise, £6,200.
2
Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as—
a
a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or
b
a payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force.
3
In this regulation—
a
a person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; and
b
“persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.
Unpaid fees57
All unpaid sums due by way of, or on account of, any fees payable under this Part are recoverable as debts due to the Crown.
Waivers, reductions and refunds58
1
The Secretary of State may—
a
waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;
b
refund the whole or part of any fee paid pursuant to this Part.
2
Without prejudice to the generality of paragraph (1), where—
a
a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or
b
an application for designation as—
i
F37an approved body under regulation 45(1), or
ii
F55a CAB under regulation 48(1),
(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,
the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.
Waivers, reductions and refunds58
1
The Secretary of State may—
a
waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;
b
refund the whole or part of any fee paid pursuant to this Part.
2
Without prejudice to the generality of paragraph (1), where—
a
a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or
b
an application for designation as—
i
a notified body under regulation 45(1), or
ii
F43a CAB under regulation 48(1),
(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,
the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.