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Medicines and Medical Devices Act 2021
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PART 2
.
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PART 2 U.K.Provisions
2U.K.In the Medical Devices Regulations 2002 (S.I. 2002/618), after the last Schedule insert, with the appropriate number, the following Schedule—
Regulation 60A
“SCHEDULEU.K.Provisions breach of which is an offence under 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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