- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (21/10/2013)
- Gwreiddiol (a wnaed Fel)
The Medical Devices Regulations 2002 is up to date with all changes known to be in force on or before 23 September 2024. There are changes that may be brought into force at a future date.
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PART I Introductory Provisions Relating to all Medical Devices
PART II General Medical Devices
9. Determining compliance of general medical devices with relevant essential requirements
11. CE marking of general medical devices that come within the scope of more than one Directive
13. Procedures for affixing a CE marking to general medical devices
14. Procedures for systems and procedure packs, and for devices to be sterilised before use
16. Procedures for general medical devices for clinical investigations
17. Manufacturers etc. and conformity assessment procedures for general medical devices
18. UK notified bodies and the conformity assessment procedures for general medical devices
19. Registration of persons placing general medical devices on the market
19A.Additional requirements relating to use of animal tissues
PART III Active Implantable Medical Devices
22. Essential requirements for active implantable medical devices
23. Determining compliance of active implantable medical devices with relevant essential requirements
25. CE marking of active implantable medical devices that come within the 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. Procedures for active implantable medical devices for clinical investigations
30. Manufacturers etc. and conformity assessment procedures for active implantable medical devices
31. UK notified bodies and the conformity assessment procedures for active implantable medical devices
PART IV In Vitro Diagnostic Medical Devices
34. Essential requirements forin vitro diagnostic medical devices
35. Determining compliance ofin vitro diagnostic medical devices with relevant essential requirements
37. CE marking ofin vitro diagnostic medical devices that come within the scope of more than one Directive
40. Procedures for affixing a CE marking toin vitro diagnostic medical devices
41. Manufacturers etc. and conformity assessment procedures forin vitro diagnostic medical devices
42. UK notified bodies and the conformity assessment procedures forin vitro diagnostic medical devices
44. Registration of manufacturers etc. ofin vitro diagnostic medical devices and devices for performance evaluation
PART V Notified Bodies, Conformity Assessment Bodies and Marking of Products
PART VI Fees charged by the Secretary of State
53. Fees in connection with the registration of devices and changes to registration details
54. Fees payable in connection with the designation etc. of UK notified bodies
55. Fees payable in connection with the designation etc. of EC conformity assessment bodies
56. Fees payable in relation to clinical investigation notices
1.The agreement on mutual recognition in relation to conformity assessment...
2.The agreement on mutual recognition in relation to conformity assessment...
3.The agreement on mutual recognition between the European Community and...
4.The agreement on mutual recognition between the European Community and...
5.The agreement between the European Community and the Swiss Confederation...
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