- Latest available (Revised)
- Point in Time (01/04/2023)
- Original (As made)
Version Superseded: 21/03/2024
Point in time view as at 01/04/2023.
There are currently no known outstanding effects for the The Medical Devices (Northern Ireland Protocol) Regulations 2021.
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Regulation 16
Commencement Information
I1Sch. 1 in force at 27.7.2021, see reg. 1(2)
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
F1Sch. 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)
F2Sum 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)
F3Sum 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)
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
F4Sch. 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)
F5Sum 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)
F6Sum 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
Commencement Information
I2Sch. 2 in force at 27.7.2021, see reg. 1(2)
Application | Fee |
---|---|
1. For initial designation submitted under Article 38 | [F7£35,672] |
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 | [F8£8,918] |
3. For reassessment under Article 44(10) | [F9£35,672] |
[F104. For an extension of the scope of the designation under Article 46(1) which extends the body’s designation to carry out tasks included in an Annex that was not previously within the body’s designation] | [F11£12,571] |
[F125. For an extension of the scope of the designation under Article 46(1) 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] | [F13£18,212] |
Textual Amendments
F7Sum 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)
F8Sum 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)
F9Sum 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)
F10Words 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)
F11Sum 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)
F12Words 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)
F13Sch. 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)
Activity | Fee |
---|---|
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) | [F14£58,341] |
2. On-site audit as part of an annual reassessment under Article 44(4) | [F15£45,675] |
3. Observed audit of notified body personnel under Article 44(5) | [F16£10,072] |
4. On-site assessment of a subsidiary | [F17£22,789] |
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) [F18£18,583] (b) [F19£22,789] |
Textual Amendments
F14Sum 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)
F15Sum 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)
F16Sum 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)
F17Sum 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)
F18Sum 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)
F19Sum 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
Commencement Information
I3Sch. 3 in force at 27.7.2021, see reg. 1(2)
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 |
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 |
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) | 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 |
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