Part IV In Vitro Diagnostic Medical Devices

United Kingdom

1. 32Interpretation of Part IV
2. 33Scope of Part IV
3. 33ARegistration etc. of persons placing in vitro diagnostic medical devices on the market
4. 34Essential requirements for in vitro diagnostic medical devices
5. 34AApproval requirement for coronavirus test devices
6. 34BPublic sector use of coronavirus test devices
7. 34CTransitional provisions for coronavirus test devices
8. 34DExemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107
9. 35Determining compliance of in vitro diagnostic medical devices with relevant essential requirements
10. 36UK marking of in vitro diagnostic medical devices
11. 36AUK(NI) indication: in vitro diagnostic medical devices
12. 37UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation
13. 38In vitro diagnostic medical devices not ready for use
14. 38AApplications for approval of coronavirus test devices
15. 38BPerformance requirements for coronavirus test devices
16. 38CRegister of approved coronavirus test devices
17. 39Exemptions from this Part
18. 39AExemptions for coronavirus test devices
19. 40Procedures for affixing a UK marking to in vitro diagnostic medical devices
20. 41Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices
21. 42Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices
22. 43Devices for performance evaluation
23. 44Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation
24. 44ZAObligations in Part IV which are met by complying with obligations in Directive 98/79
25. 44ZBObligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746