The Medical Devices (Northern Ireland Protocol) Regulations 2021

Regulation 16

SCHEDULE 1 N.I. Fees for clinical investigations

Commencement Information

I1 Sch. 1 in force at 27.7.2021, see reg. 1(2)

Table 1

[F1 Clinical investigation of a class I device, class IIa device or class IIb device, which is neither an implantable device nor a long-term invasive device]

Activity	Fee
1. Application submitted under Article 70(1)	[F2 £7,472]
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)	[F3 £5,711]
3. Notification of a substantial modification under Article 75(1)	£207

Textual Amendments

F1 Sch. 1 Table 1 heading substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(2)

F2 Sum in Sch. 1 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(3)(a)

F3 Sum in Sch. 1 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(3)(b)

Table 2

[F4 Clinical investigation of a class IIb device, which is either an implantable device or a long-term invasive device, or a class III device]

Activity	Fee
1. Application submitted under Article 70(1)	[F5 £15,627]
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)	[F6 £11,069]
3. Notification of a substantial modification under Article 75(1)	£331

Textual Amendments

F4 Sch. 1 Table 2 heading substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(4)

F5 Sum in Sch. 1 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(5)(a)

F6 Sum in Sch. 1 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 24(5)(b)

Regulation 19

SCHEDULE 2 U.K. Fees in connection with the designation of notified bodies

Commencement Information

I2 Sch. 2 in force at 27.7.2021, see reg. 1(2)

Table 1

Application fees

Application	Fee
1. For initial designation submitted under Article 38 [F7 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746]	[F8 £35,672]
2. For initial designation re-submitted under Article 38 [F9 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746] where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application	[F10 £8,918]
3. For reassessment under Article 44(10) [F11 of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746]	[F12 £35,672]
[F13 4. For an extension of the scope of the designation under Article 46(1) [F14 of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746] which extends the body’s designation to carry out tasks included in an Annex [F15 to Regulation (EU) 2017/745 or Regulation (EU) 2017/746] that was not previously within the body’s designation]	[F16 £12,571]
[F17 5. For an extension of the scope of the designation under Article 46(1) [F18 of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746] which extends the body’s designation to carry out tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required]	[F19 £18,212]

Textual Amendments

F7 Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(i)

F8 Sum in Sch. 2 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(3)(a)

F9 Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(ii)

F10 Sum in Sch. 2 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(3)(b)

F11 Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iii)

F12 Sum in Sch. 2 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(3)(c)

F13 Words in Sch. 2 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(2)(a)

F14 Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iv)(aa)

F15 Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iv)(bb)

F16 Sum in Sch. 2 Table 1 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(3)(d)

F17 Words in Sch. 2 Table 1 inserted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(2)(b)

F18 Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(v)

F19 Sch. 2 Table 1 sum inserted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(3)(e)

Table 2

Fees for assessments and reviews

Activity	Fee
1. On-site assessment under Article 39(4) [F20 of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746] in connection with an application for initial designation under Article 38 [F21 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746], or an application for reassessment under Article 44(10) [F22 of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746]	[F23 £58,341]
2. On-site audit as part of an annual reassessment under Article 44(4) [F24 of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746]	[F25 £45,675]
3. Observed audit of notified body personnel under Article 44(5) [F26 of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746]	[F27 £10,072]
4. On-site assessment of a subsidiary	[F28 £22,789]
5. ‘For-cause’ review under Article 44(7) [F29 of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746] to— (a) review assessments by the notified body, including clinical evaluation documentation; (b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 [F30 , or Regulation (EU) 2017/746] or address a particular issue	(a) [F31 £18,583] (b) [F32 £22,789]

Textual Amendments

F20 Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(aa)

F21 Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(bb)

F22 Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(cc)

F23 Sum in Sch. 2 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(4)(a)

F24 Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(ii)

F25 Sum in Sch. 2 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(4)(b)

F26 Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iii)

F27 Sum in Sch. 2 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(4)(c)

F28 Sum in Sch. 2 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(4)(d)

F29 Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iv)(aa)

F30 Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iv)(bb)

F31 Sum in Sch. 2 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(4)(e)(i)

F32 Sum in Sch. 2 Table 2 substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 25(4)(e)(ii)

Regulation 23

SCHEDULE 3 N.I. Provisions breach of which is an offence under regulation 23

Commencement Information

I3 Sch. 3 in force at 27.7.2021, see reg. 1(2)

[F33 Table 1

Regulation	Title of the regulation
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 under Regulation (EU) 2017/745
10B	Retention of documentation relating to conformity assessments
10C	UK(NI) indication under Regulation (EU) 2017/746
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
17C	Ethical review of performance studies
17E	Damage compensation in relation to performance studies
17F	Retention of documentation relating to performance studies]

Textual Amendments

F33 Sch. 3 Table 1 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(a)

Table 2

Article	Title of the article
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)	[F34 general obligations of 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
[F35 32(1) (except the second sentence of the third sub-paragraph), (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
[F36 86 (except the second and third sentences of paragraph (2))]	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

Textual Amendments

F34 Words in Sch. 3 Table 2 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(b)(i)

F35 Words in Sch. 3 Table 2 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(b)(ii)

F36 Words in Sch. 3 Table 2 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(b)(iii)

[F37 Table 3

Article	Title of the article
5(1) to (3), (5)	Placing on the market and putting into service
6(1) to (3)	Distance sales
7	Claims
9(3)	Common specifications
10 (except the second, third or fourth sub-paragraphs of paragraph 13)	General obligations of 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
20(1)	Parts and components
22	Identification within the supply chain
29(1) (except the second sentence of the third sub-paragraph), (2)	Summary of safety and performance
48(1), (2), (3) (except the third sub-paragraph), (4) (except the second sub-paragraph), (7) (except the third sub-paragraph), (8) (except the second sub-paragraph), (9) and (10)	Conformity assessment procedures
49(3)	Involvement of notified bodies in conformity assessment procedures
53(1)	Voluntary change of notified body
57	General requirements regarding performance studies
58(1), (2), (4) (except the second sub-paragraph), (5), (6) and (8)	Additional requirements for certain performance studies
79	Post-market surveillance plan
80	Post-market surveillance report
81 (except the second and third sentences of paragraph (2))	Periodic safety update report
84(1), (3) (except the first sub-paragraph), (5) and (8)	Analysis of serious incidents and field safety corrective actions
89 (only the final paragraph)	Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance]

Textual Amendments

F37 Sch. 3 Table 3 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(c)