Regulation 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 ”.