Schedule 3 Provisions breach of which is an offence under regulation 23I1
Northern Ireland
F1Table 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 |
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) | F2general 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 |
| F332(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 |
| F486 (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 |
F5Table 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 |
Annotations
Textual amendments
- F1
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)
- F2
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)
- F3
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)
- F4
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)
- F5
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)
Commencement
- I1
Sch. 3 in force at 27.7.2021, see reg. 1(2)