The Medical Devices Regulations 2002

1. Introductory Text

2. PART I Introductory Provisions Relating to all Medical Devices

   1. 1. Citation and commencement

   2. 2. Interpretation

   3. 3. Scope of these Regulations

   4. 4. Transitional provisions

   5. 4A. Transitional provisions for hip, knee and shoulder replacements

3. PART II General Medical Devices

   1. 5. Interpretation of Part II

   2. 6. Scope of Part II

   3. 7. Classification of general medical devices

   4. 8. Essential requirements for general medical devices

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

   6. 10. CE marking of general medical devices

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

   8. 12. Exemptions from regulations 8 and 10

   9. 13. Procedures for affixing a CE marking to general medical devices

   10. 14. Procedures for systems and procedure packs, and for devices to be sterilised before use

   11. 15. Procedures for custom-made general medical devices

   12. 16. Procedures for general medical devices for clinical investigations

   13. 17. Manufacturers etc. and conformity assessment procedures for general medical devices

   14. 18. UK notified bodies and the conformity assessment procedures for general medical devices

   15. 19. Registration of persons placing general medical devices on the market

   16. 19A. Additional requirements relating to use of animal tissues

4. PART III Active Implantable Medical Devices

   1. 20. Interpretation of Part III

   2. 21. Scope of Part III

   3. 22. Essential requirements for active implantable medical devices

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

   5. 24. CE marking of active implantable medical devices

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

   7. 26. Exemptions from regulations 22 and 24

   8. 27. Procedures for affixing a CE marking to active implantable medical devices

   9. 28. Procedures for custom-made active implantable medical devices

   10. 29. Procedures for active implantable medical devices for clinical investigations

   11. 30. Manufacturers etc. and conformity assessment procedures for active implantable medical devices

   12. 31. UK notified bodies and the conformity assessment procedures for active implantable medical devices

5. PART IV In Vitro Diagnostic Medical Devices

   1. 32. Interpretation of Part IV

   2. 33. Scope of Part IV

   3. 34. Essential requirements forin vitro diagnostic medical devices

   4. 35. Determining compliance ofin vitro diagnostic medical devices with relevant essential requirements

   5. 36. CE marking ofin vitro diagnostic medical devices

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

   7. 38. In vitro diagnostic medical devices not ready for use

   8. 39. Exemptions from regulations 34, 36 and 38

   9. 40. Procedures for affixing a CE marking toin vitro diagnostic medical devices

   10. 41. Manufacturers etc. and conformity assessment procedures forin vitro diagnostic medical devices

   11. 42. UK notified bodies and the conformity assessment procedures forin vitro diagnostic medical devices

   12. 43. Devices for performance evaluation

   13. 44. Registration of manufacturers etc. ofin vitro diagnostic medical devices and devices for performance evaluation

6. PART V Notified Bodies, Conformity Assessment Bodies and Marking of Products

   1. 44A. Interpretation of Part V

   2. 45. Designation etc. of UK notified bodies

   3. 46. Choice of notified bodies and conformity assessment bodies

   4. 47. General matters relating to UK notified bodies

   5. 48. Designation etc. of EC conformity assessment bodies

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

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

   8. 51. Products incorrectly marked with a CE marking

7. PART VI Fees charged by the Secretary of State

   1. 52. Interpretation of Part VI

   2. 53. Fees in connection with the registration of devices and changes to registration details

   3. 54. Fees payable in connection with the designation etc. of UK notified bodies

   4. 55. Fees payable in connection with the designation etc. of EC conformity assessment bodies

   5. 56. Fees payable in relation to clinical investigation notices

   6. 57. Unpaid fees

   7. 58. Waivers, reductions and refunds

8. PART VII General, Enforcement and Miscellaneous

   1. 59. Interpretation of Part VII

   2. 60. Designation etc. of authorised representatives

   3. 61. Enforcement etc.

   4. 62. Compliance notices

   5. 63. Restriction notices

   6. 64. Notification of decisions etc.

   7. 65. Centralised systems of records etc.

   8. 66. Revocations

9. Signature

10. 1. SCHEDULE 1

       ASSOCIATION AGREEMENTS

       1. 1. The Protocol to the Europe Agreement establishing an Association between...

    2. SCHEDULE 2

       MUTUAL RECOGNITION AGREEMENTS

       1. 1. The agreement on mutual recognition in relation to conformity assessment...

       2. 2. The agreement on mutual recognition in relation to conformity assessment...

       3. 3. The agreement on mutual recognition between the European Community and...

       4. 4. The agreement on mutual recognition between the European Community and...

11. Explanatory Note