# Medicines and Medical Devices Act 2021, Paragraph 2

Status: prospective

In the Medical Devices Regulations 2002 (S.I. 2002/618), after the last Schedule insert, with the appropriate number, the following Schedule—
“SCHEDULE
Provisions breach of which is an offence under regulation 60A
Regulation 60A
The regulations referred to in regulation 60A(1) are—
Regulation
Description
8(1), (2)
Essential requirements for general medical devices
10(1) to (5)
CE marking of general medical devices
11
CE marking of general medical devices within scope of more than one Directive
13(1) to (4)
Procedures for affixing a CE marking to general medical devices
14(1), (2), (5)
Procedures for systems and procedure packs, and for devices to be sterilised before use
15
Procedures for custom-made general medical devices
16(1), (4), (7), (10)
Procedures for general medical devices for clinical investigation
17(1), (2)
Manufacturers etc and conformity assessment procedures for general medical devices
19
Registration of persons placing general medical devices on the market
22
Essential requirements for active implantable medical devices
24
CE marking of active implantable medical devices
25
CE marking of active implantable medical devices within scope of more than one Directive
27
Procedures for affixing a CE marking to active implantable medical devices
28
Procedures for custom-made active implantable medical devices
29(1), (3), (6), (7), (9)
Procedures for active implantable medical devices for clinical investigations
30(1)
Manufacturers etc and conformity assessment procedures for active implantable medical devices
34
Essential requirements for in vitro diagnostic medical devices
36(1) to (5)
CE marking of in vitro diagnostic medical devices
37
CE marking of in vitro diagnostic medical devices within scope of more than one Directive
38
In vitro diagnostic medical devices not ready for use
40
Procedures for affixing a CE marking to in vitro diagnostic medical devices
41(1), (2), (3)
Manufacturers etc and conformity assessment procedures for in vitro diagnostic medical devices
43
Devices for performance evaluation
44
Registration of manufacturers etc of in vitro diagnostic medical devices and devices for performance evaluation
50(1)(a) and (b), (2), (3)
Products incorrectly marked with a notified body or conformity assessment body number
51(1), (2)
Products incorrectly marked with a CE marking
”

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Source: https://www.legislation.gov.uk/ukpga/2021/3/schedule/3/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-and-medical-devices-act-2021/schedule-3/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.