1. Application submitted under Article 70(1)

£3,820

2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)

£2,920

3. Notification of a substantial modification under Article 75(1)

£207

1. Application submitted under Article 70(1)

£5,040

2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)

£3,570

3. Notification of a substantial modification under Article 75(1)

£331

1. For initial designation submitted under Article 38

£8,252

2. For initial designation re-submitted under Article 38 where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application

£2,063

3. For reassessment under Article 44(10)

£8,252

4. For an extension of the scope of the designation under Article 46(1)

£6,504

1. On-site assessment under Article 39(4) in connection with an application for initial designation under Article 38, or an application for reassessment under Article 44(10)

£15,904

2. On-site audit as part of an annual reassessment under Article 44(4)

£10,160

3. Observed audit of notified body personnel under Article 44(5)

£4,404

4. On-site assessment of a subsidiary

£3,876

5. ‘For-cause’ review under Article 44(7) to—

(a) review assessments by the notified body, including clinical evaluation documentation;

(b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 or address a particular issue

(a) £2,586

(b) £3,876

5

Reprocessing of single-use devices

6

Requirement on health institutions relating to implanted devices

7

Provision of information relating to custom-made devices

9

Retention of documentation relating to conformity assessments and custom-made devices

10

UK(NI) indication

11

Ethical review of clinical investigations

12(1)

Prior authorisation of clinical investigations by the Secretary of State

14

Damage compensation in relation to clinical investigations

15

Retention of documentation relating to clinical investigations

5(1) to (3), (5)

Placing on the market and putting into service

6(1)-(3)

Distance sales

7

Claims

9(3), (4)

Common specifications

10 (except in paragraph 14, only the first sub-paragraph)

General obligations on manufacturers

11(1), (3), (6)

Authorised representative

12

Change of authorised representative

13

General obligations of importers

14

General obligations of distributors

15

Person responsible for regulatory compliance

16(3), (4)

Cases in which obligations of manufacturers apply to importers, distributors or other persons.

17(1)

Single-use devices and their reprocessing

18(1)

Implant card and information to be supplied to the patient with an implanted device

21(2)

Devices for special purposes

22(1), (3) to (5)

Systems and procedure packs

23(1)

Parts and components

25(1), (2)

Identification within the supply chain

32(1), (2)

Summary of safety and clinical performance

52(1) to (4), (6) to (11), (13)

Conformity assessment procedures

53(3)

Involvement of notified bodies in conformity assessment procedures

58(1)

Voluntary change of notified body

62(1), (2) (only the first sub-paragraph), (3) (only the first sub-paragraph), (4), (5), (7)

General requirements regarding clinical investigations conducted to demonstrate conformity of devices

82(1)

Requirements regarding other clinical investigations

84

Post-market surveillance plan

85

Post-market surveillance report

86

Periodic safety update report

89(1), (3) (only the second sub-paragraph),(5), (8)

Analysis of serious incidents and field safety corrective actions

94 (only the final paragraph)

Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance