The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)

44.  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”.