MHRA Medical Devices Regulations 2002

The Medical Devices Regulations 2002

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972(a) in relation to measures relating to medical devices(b), in exercise of the powers conferred by the said section 2(2), in exercise, with the consent of the Treasury, of the powers conferred by section 56(1) and (2) of the Finance Act 1973(c), in exercise of the powers conferred by sections 11 and 27(2) of the Consumer Protection Act 1987(d), and in exercise of all other powers enabling him in that behalf, after consultation in accordance with section 11(5) of the Consumer Protection Act 1987 with organisations appearing to him to be representative of interests substantially affected by these Regulations, with such other persons considered by him appropriate and with the Health and Safety Commission, hereby makes the following Regulations; and come into force - 13 June 2002.

Table of Contents

PART I

Introductory Provisions Relating to all Medical Devices

1. Citation and commencement

2. Interpretation

3. Scope of these Regulations

4. Transitional provisions

PART II

General Medical Devices

5. Interpretation of Part II

6. Scope of Part II

7. Classification of general medical devices

8. Essential requirements for general medical devices

9. Determining compliance of general medical devices with relevant essential requirements

10. CE marking of general medical devices

11. CE marking of general medical devices that come within the scope of more than one Directive

12. Exemptions from regulations 8and 10

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

15. Procedures for custom-made general medical devices

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

PART III

Active Implantable Medical Devices

20. Interpretation of Part III

21. Scope of Part III

22. Essential requirements for active implantable medical devices

23. Determining compliance of active implantable medical devices with relevant essential requirements

24. CE marking of active implantable medical devices

25. CE marking of active implantable medical devices that come within the scope of more than one Directive

26. Exemptions from regulations 22and 24

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

32. Interpretation of Part IV

33. Scope of Part IV

34. Essential requirements for invitro diagnostic medical devices

35. Determining compliance of invitro diagnostic medical devices with relevant essential requirements

36. CE marking of in vitro diagnostic medical devices

37. CE marking of in vitro diagnostic medical devices that come within the scope of more than one Directive

38. In vitro diagnostic medical devices not ready for use

39. Exemptions from regulations 34,36 and 38

40. Procedures for affixing a CE marking to in vitro diagnostic medical devices

41. Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices

42. UK notified bodies 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

PART V

Notified Bodies, Conformity Assessment Bodies and Marking of Products

45. Designation etc. of UK notified bodies

46. Choice of notified bodies and conformity assessment bodies

47. General matters relating to notified bodies

48. Designation etc. of EC conformity assessment bodies

49. Fees charged by UK notified bodies and EC conformity assessment bodies

50. Products incorrectly marked with a notified body or conformity assessment body number

51. Products incorrectly marked with a CE marking

PART VI

Fees Charged by the Secretary of State

52. Interpretation of Part VI

53. Fees payable in connection with 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 connection with clinical investigation notices

57. Unpaid fees

58. Waivers, reductions and refunds

PART VII

General, Enforcement and Miscellaneous

59. Interpretation of Part VII

60. Designation etc. of authorised representatives

61. Enforcement etc.

62. Compliance notices

63. Restriction notices

64. Notification of Decisions etc.

65. Centralised systems of records

66. Revocations

SCHEDULES

1. Association Agreements

2. Mutual Recognition Agreements

MHRA Medical Devices Regulations 2002: