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