The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
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Change 1
44 Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)
In Schedule 3— (a) for Table 1 substitute— 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 (b) in Table 2— (i) for “general obligations on manufacturers” substitute “general obligations of manufacturers”; (ii) for “32(1), (2)” substitute “32(1) (except the second sentence of the third sub-paragraph), (2)”; (iii) for “86” substitute “86 (except the second and third sentences of paragraph (2))”; (c) after Table 2 insert— 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 .
44 Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)
In Schedule 3— (a) for Table 1 substitute— 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 (b) in Table 2— (i) for “general obligations on manufacturers” substitute “general obligations of manufacturers”; (ii) for “32(1), (2)” substitute “32(1) (except the second sentence of the third sub-paragraph), (2)”; (iii) for “86” substitute “86 (except the second and third sentences of paragraph (2))”; (c) after Table 2 insert— 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 .
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