The Medical Devices Regulations 2002

1. Introductory Text

2. PART I Introductory Provisions Relating to all Medical Devices

   1. 1. Citation and commencement

   2. 1ZA. Expiry of certain provisions in these Regulations

   3. 1A. Schedules

   4. 2. Interpretation

   5. 2A. Medical devices which are qualifying Northern Ireland goods

   6. 3. Scope of these Regulations

   7. 3A. Designated standard

   8. 3B. Confidentiality

   9. 4. Transitional provisions

   10. 4A. Transitional provisions for hip, knee and shoulder replacements

   11. 4D. Revocations, transitional and saving provisions in respect of the new national registration requirements

   12. 4H. Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date

   13. 4I. Revocation of Commission Decision 2010/227

   14. 4J. Revocation of Regulation (EU) No 207/2012 on 26th May 2025 and its effect before that date

   15. 4K. Revocation of Regulation (EU) No 722/2012 on 26th May 2025 and its effect before that date

   16. 4L. Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date

   17. 4M. Revocation of Regulation (EU) No 2017/2185 and saving provision

   18. 4N. The classification criteria in Directives 2003/12 and 2005/50

   19. 4O. Revocation of Regulation (EU) 2017/745

   20. 4P. Revocation of Regulation (EU) 2017/746

   21. 4T. References in other legislation to Directives 90/385, 93/42 and 98/79

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. UK marking of general medical devices

   7. 10A. UK(NI) indication: general medical devices

   8. 11. UK marking of general medical devices that come within the scope of this Part and other legislation

   9. 12. Exemptions from regulations 8 and 10

   10. 13. Procedures for affixing a UK marking to general medical devices

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

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

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

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

   15. 18. Approved bodies and the conformity assessment procedures for general medical devices

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

   17. 19A. Additional requirements relating to use of animal tissues

   18. 19B. Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42

   19. 19C. Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745

4. PART III Active Implantable Medical Devices

   1. 20. Interpretation of Part III

   2. 21. Scope of Part III

   3. 21B. Registration of persons placing active implantable medical devices on the market

   4. 21C. Requirement to appoint a UK responsible person for active implantable medical devices

   5. 22. Essential requirements for active implantable medical devices

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

   7. 24. UK marking of active implantable medical devices

   8. 24A. UK(NI) indication: active implantable medical devices

   9. 25. UK marking of active implantable medical devices that come within the scope of this Part and other legislation

   10. 26. Exemptions from regulations 22 and 24

   11. 27. Procedures for affixing a UK marking to active implantable medical devices

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

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

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

   15. 30A. Obligations in Part III which are met by complying with obligations in Directive 90/385

   16. 31. Approved 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 for in vitro diagnostic medical devices

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

   5. 36. UK marking of in vitro diagnostic medical devices

   6. 36A. UK(NI) indication: in vitro diagnostic medical devices

   7. 37. UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation

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

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

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

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

   12. 42. Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices

   13. 43. Devices for performance evaluation

   14. 44. Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation

   15. 44ZA. Obligations in Part IV which are met by complying with obligations in Directive 98/79

   16. 44ZB. Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746

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

   1. 44A. Interpretation of Part V

   2. A45. Meaning of approved body and UK notified body

   3. 45. Designation etc. of approved bodies

   4. 46. Choice of approved bodies and conformity assessment bodies

   5. 47. General matters relating to approved bodies

   6. 47A. Register of approved bodies

   7. 48. Designation etc. of ... conformity assessment bodies

   8. 49. Fees charged by approved bodies and conformity assessment bodies

   9. 50. Products incorrectly marked with an approved body or conformity assessment body number

   10. 51. Products incorrectly marked with a UK 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 of approved 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. Status of UK responsible person

   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. 67. Review

9. Signature

10. 1. SCHEDULE 1

       ASSOCIATION AGREEMENTS

       1. 1. The Agreement establishing an Association between the European Economic Community...

    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...

       5. 5. The agreement between the European Community and the Swiss Confederation...

    3. SCHEDULE 2

       Mutual Recognition Agreement countries

       1. — Australia — New Zealand — Canada — The United...

    4. SCHEDULE 2A

       Modification of Annexes to Directives 90/385, 93/42, 98/79

       1. PART 1 Modification of Annexes to Directive 90/385

          1. 1. (1) The Annexes to Directive 90/385 are modified so that...

          2. 2. In Annex 1— (a) in Section 8 for the fifth...

          3. 3. In Annex 2— (a) for the heading substitute “Declaration of...

          4. 4. In Annex 3— (a) in the title for “EC TYPE-EXAMINATION”...

          5. 5. For Annex 4 substitute— ANNEX 4 VERIFICATION Verification is the procedure whereby the manufacturer ensures and declares...

          6. 6. For Annex 5, substitute— ANNEX 5 DECLARATION OF CONFORMITY TO...

          7. 7. In Annex 6— (a) in Section 1, for “authorised representative...

          8. 8. In Annex 7, in Section 2.3.5, for “all competent authorities...

          9. 9. In Annex 8— (a) in the title for “when designating...

          10. 10. Omit Annex 9.

       2. PART 2 Modification of Annexes to Directive 93/42

          1. 11. (1) The Annexes to Directive 93/42 are modified so that...

          2. 12. In Annex I— (a) in Section 3, for “Article 1(2)(a)”...

          3. 13. In Annex II— (a) in the title omit “EC”;

          4. 14. In Annex III— (a) for each reference to “EC type-examination”...

          5. 15. In Annex IV— (a) omit “EC” (including in the title)...

          6. 16. In Annex V— (a) for “notified body” each time it...

          7. 17. In Annex VI— (a) omit “EC” each time it occurs...

          8. 18. In Annex VII— (a) in the title and in Section...

          9. 19. In Annex VIII— (a) in Section 1, for “authorized representative”...

          10. 20. In Annex IX for “this Directive” each time it occurs...

          11. 21. In Annex X— (a) in Section 1.1 for “harmonised standards”...

          12. 22. In Annex X1— (a) in the title, for “notified bodies”...

          13. 23. Omit Annex XII.

       3. PART 3 Modification of Annexes to Directive 98/79

          1. 24. (1) The Annexes to Directive 98/79 are modified so that...

          2. 25. In Annex 1— (a) in Section 3 in part A,...

          3. 26. In Annex III— (a) in the title and in Section...

          4. 27. In Annex IV— (a) in the title, omit “EC”;

          5. 28. In Annex V— (a) in the title, omit “EC” ;...

          6. 29. In Annex VI— (a) in the title omit “EC”;

          7. 30. In Annex VII— (a) in the title and in Section...

          8. 31. In Annex VIII— (a) in Section 1—

          9. 32. In Annex IX— (a) in the title, for “notified bodies”...

          10. 33. Omit Annex X.

11. Explanatory Note