OpenLegislation

The Medical Devices Regulations 2002 in Northern Ireland

S.I. 2002/618 · Made 20 May 2002 · Extends to United Kingdom

Not fully up to date. 4 changes made by later legislation have not yet been written into this text, which is revised to 1 April 2026.

See the changes not yet applied
ProvisionChangeMade by
reg. 60AexcludedMedicines and Medical Devices Act 2021 Sch. 2 para. 4
reg. 60AexcludedMedicines and Medical Devices Act 2021 Sch. 2 para. 5(2)
reg. 60A-60CinsertedMedicines and Medical Devices Act 2021 Sch. 3 para. 1
Sch. 3insertedMedicines and Medical Devices Act 2021 Sch. 3 para. 2

CONSUMER PROTECTION

Made 20th May 2002

Laid before Parliament 21st May 2002

Coming into force 13th June 2002

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972M1 in relation to measures relating to medical devicesM2, 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 1973M3, in exercise of the powers conferred by sections 11 and 27(2) of the Consumer Protection Act 1987M4, 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:—C1

Annotations to the whole text

Marginal citations

M1

1972 c. 68.

M2

The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.

M3

1973 c. 51.

M4

1987 c. 43.

Modifications

C1

Regulations: power to amend conferred (11.2.2021) by Medicines and Medical Devices Act 2021 (c. 3), ss. 15(1), 50(1)(f)

Contents

  1. Part I: Introductory Provisions Relating to all Medical Devices
  2. 1Citation and commencement
  3. 3ZARevocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  4. 4Transitional provisions
  5. 4ATransitional provisions for hip, knee and shoulder replacements
  6. Part II: General Medical Devices
  7. 5Interpretation of Part II
  8. 6Scope of Part II
  9. 7ARegistration of persons placing general medical devices on the market
  10. 10AUK(NI) indication: general medical devices
  11. 19Registration of persons placing general medical devices on the market
  12. 19AAdditional requirements relating to use of animal tissues Repealed
  13. 19BObligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42
  14. Part III: Active Implantable Medical Devices
  15. 20Interpretation of Part III
  16. 21ARegistration of persons placing active implantable medical devices on the market
  17. 21BRegistration of persons placing active implantable medical devices on the market
  18. 21CRequirement to appoint a UK responsible person for active implantable medical devices Repealed
  19. 22Essential requirements for active implantable medical devices
  20. 24AUK(NI) indication: active implantable medical devices
  21. Part IV: In Vitro Diagnostic Medical Devices
  22. 33Scope of Part IV
  23. 33ARegistration etc. of persons placing in vitro diagnostic medical devices on the market
  24. 34Essential requirements for in vitro diagnostic medical devices
  25. 34AApproval requirement for coronavirus test devices
  26. 34BPublic sector use of coronavirus test devices
  27. 34CTransitional provisions for coronavirus test devices
  28. 34DExemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107
  29. 36AUK(NI) indication: in vitro diagnostic medical devices
  30. 38In vitro diagnostic medical devices not ready for use
  31. 38AApplications for approval of coronavirus test devices
  32. 38BPerformance requirements for coronavirus test devices
  33. 38CRegister of approved coronavirus test devices
  34. 39AExemptions for coronavirus test devices
  35. 44Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation
  36. 44ZAObligations in Part IV which are met by complying with obligations in Directive 98/79
  37. 44ZCInterpretation of Part 4A
  38. 44ZDScope of Part 4A
  39. 44ZEPost-market surveillance system
  40. 44ZFPost-market surveillance plan
  41. 44ZGPreventive and corrective actions
  42. 44ZHInitial reporting of serious incidents
  43. 44ZIInvestigation and final reporting of serious incidents
  44. 44ZJField safety corrective actions and field safety notices
  45. 44ZKField safety corrective actions outside Great Britain
  46. 44ZLPost-market surveillance report
  47. 44ZMPeriodic safety update report
  48. 44ZNTrend reporting
  49. 44ZOReports received by the Secretary of State
  50. 44ZPAnalysis of information received under Part 4A
  51. 44ZQRetention of post-market surveillance documentation
  52. 44ZRRequests for post-market surveillance documentation
  53. Part V: Notified Bodies Approved Bodies, Conformity Assessment Bodies and Marking of Products
  54. 44AInterpretation of Part V
  55. 52Interpretation of Part VI
  56. 56AFees in connection with approval of coronavirus test devices
  57. 56EFees payable in connection with regulatory advice meetings
  58. 57Unpaid fees
  59. 58ATime for payment of fees - small companies
  60. Part VII: General, Enforcement and Miscellaneous
  61. 59Interpretation of Part VII
  62. 62Compliance notices Repealed
  63. 63Restriction notices Repealed
  64. 64Notification of decisions etc. Repealed
  65. 65Centralised systems of records etc.
  66. 66Revocations
  67. Signature
  68. Schedule 1: ASSOCIATION AGREEMENTS
  69. 1Paragraph 1
  70. Schedule 2: MUTUAL RECOGNITION AGREEMENTS
  71. 1Paragraph 1
  72. 2Paragraph 2
  73. 3Paragraph 3
  74. 4Paragraph 4
  75. 5Paragraph 5
  76. 1Paragraph 1
  77. 4Paragraph 4
  78. 5Paragraph 5
  79. 6Paragraph 6
  80. 7Paragraph 7
  81. 10Paragraph 10
  82. Part 2: Modification of Annexes to Directive 93/42
  83. 11Paragraph 11
  84. 12Paragraph 12
  85. 14Paragraph 14
  86. 16Paragraph 16
  87. 18Paragraph 18
  88. 19Paragraph 19
  89. 20Paragraph 20
  90. 21Paragraph 21
  91. 23Paragraph 23
  92. Part 3: Modification of Annexes to Directive 98/79
  93. 24Paragraph 24
  94. 25Paragraph 25
  95. 26Paragraph 26
  96. 27Paragraph 27
  97. 28Paragraph 28
  98. 29Paragraph 29
  99. 30Paragraph 30
  100. 31Paragraph 31
  101. 32Paragraph 32
  102. 33Paragraph 33
  103. Explanatory note