SCHEDULE 3Provisions breach of which is an offence under regulation 23
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 |
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 |
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 |