Paragraph 2

Not yet in force

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
”

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