OpenLegislation

The Medical Devices Regulations 2002

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. 1ZAExpiry of certain provisions in these Regulations
  4. 1ASchedules
  5. 2Interpretation
  6. 2AMedical devices which are qualifying Northern Ireland goods
  7. 3Scope of these Regulations
  8. 3ZARevocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  9. 3ADesignated standard
  10. 3BConfidentiality Repealed
  11. 4Transitional provisions
  12. 4ATransitional provisions for hip, knee and shoulder replacements
  13. 4DRevocations, transitional and saving provisions in respect of the new national registration requirements
  14. 4HRevocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date Repealed
  15. 4IRevocation of Commission Decision 2010/227
  16. 4JRevocation of Commission Regulation (EU) No 207/2012 on 26th May 2025 Repealed
  17. 4KRevocation of Regulation (EU) No 722/2012 on 26th May 2025 Repealed
  18. 4LRevocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date Repealed
  19. 4MRevocation of Regulation (EU) No 2017/2185 and saving provision
  20. 4NThe classification criteria in Directives 2003/12 and 2005/50 Repealed
  21. 4ORevocation of Regulation (EU) 2017/745
  22. 4PRevocation of Regulation (EU) 2017/746
  23. 4TReferences in other legislation to Directives 90/385, 93/42 and 98/79
  24. Part II: General Medical Devices
  25. 5Interpretation of Part II
  26. 6Scope of Part II
  27. 7Classification of general medical devices
  28. 7ARegistration of persons placing general medical devices on the market
  29. 8Essential requirements for general medical devices
  30. 9Determining compliance of general medical devices with relevant essential requirements
  31. 10UK marking of general medical devices
  32. 10AUK(NI) indication: general medical devices
  33. 11UK marking of general medical devices that come within the scope of this Part and other legislation
  34. 12Exemptions from regulations 8 and 10
  35. 13Procedures for affixing a UK marking to general medical devices
  36. 14Procedures for systems and procedure packs, and for devices to be sterilised before use
  37. 15Procedures for custom-made general medical devices
  38. 16Procedures for general medical devices for clinical investigations
  39. 17Manufacturers etc. and conformity assessment procedures for general medical devices
  40. 18Approved bodies and the conformity assessment procedures for general medical devices
  41. 19Registration of persons placing general medical devices on the market
  42. 19AAdditional requirements relating to use of animal tissues Repealed
  43. 19BObligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42
  44. 19CObligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745
  45. Part III: Active Implantable Medical Devices
  46. 20Interpretation of Part III
  47. 21Scope of Part III
  48. 21ARegistration of persons placing active implantable medical devices on the market
  49. 21BRegistration of persons placing active implantable medical devices on the market
  50. 21CRequirement to appoint a UK responsible person for active implantable medical devices Repealed
  51. 22Essential requirements for active implantable medical devices
  52. 23Determining compliance of active implantable medical devices with relevant essential requirements
  53. 24UK marking of active implantable medical devices
  54. 24AUK(NI) indication: active implantable medical devices
  55. 25UK marking of active implantable medical devices that come within the scope of this Part and other legislation
  56. 26Exemptions from regulations 22 and 24
  57. 27Procedures for affixing a UK marking to active implantable medical devices
  58. 28Procedures for custom-made active implantable medical devices
  59. 29Procedures for active implantable medical devices for clinical investigations
  60. 30Manufacturers etc. and conformity assessment procedures for active implantable medical devices
  61. 30AObligations in Part III which are met by complying with obligations in Directive 90/385
  62. 31Approved bodies and the conformity assessment procedures for active implantable medical devices
  63. Part IV: In Vitro Diagnostic Medical Devices
  64. 32Interpretation of Part IV
  65. 33Scope of Part IV
  66. 33ARegistration etc. of persons placing in vitro diagnostic medical devices on the market
  67. 34Essential requirements for in vitro diagnostic medical devices
  68. 34AApproval requirement for coronavirus test devices
  69. 34BPublic sector use of coronavirus test devices
  70. 34CTransitional provisions for coronavirus test devices
  71. 34DExemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107
  72. 35Determining compliance of in vitro diagnostic medical devices with relevant essential requirements
  73. 36UK marking of in vitro diagnostic medical devices
  74. 36AUK(NI) indication: in vitro diagnostic medical devices
  75. 37UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation
  76. 38In vitro diagnostic medical devices not ready for use
  77. 38AApplications for approval of coronavirus test devices
  78. 38BPerformance requirements for coronavirus test devices
  79. 38CRegister of approved coronavirus test devices
  80. 39Exemptions from this Part
  81. 39AExemptions for coronavirus test devices
  82. 40Procedures for affixing a UK marking to in vitro diagnostic medical devices
  83. 41Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices
  84. 42Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices
  85. 43Devices for performance evaluation
  86. 44Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation
  87. 44ZAObligations in Part IV which are met by complying with obligations in Directive 98/79
  88. 44ZBObligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746
  89. Part 4A: Post-market surveillance requirements
  90. 44ZCInterpretation of Part 4A
  91. 44ZDScope of Part 4A
  92. 44ZEPost-market surveillance system
  93. 44ZFPost-market surveillance plan
  94. 44ZGPreventive and corrective actions
  95. 44ZHInitial reporting of serious incidents
  96. 44ZIInvestigation and final reporting of serious incidents
  97. 44ZJField safety corrective actions and field safety notices
  98. 44ZKField safety corrective actions outside Great Britain
  99. 44ZLPost-market surveillance report
  100. 44ZMPeriodic safety update report
  101. 44ZNTrend reporting
  102. 44ZOReports received by the Secretary of State
  103. 44ZPAnalysis of information received under Part 4A
  104. 44ZQRetention of post-market surveillance documentation
  105. 44ZRRequests for post-market surveillance documentation
  106. Part V: Notified Bodies Approved Bodies, Conformity Assessment Bodies and Marking of Products
  107. 44AInterpretation of Part V
  108. A45Meaning of approved body and UK notified body
  109. 45Designation etc. of approved bodies
  110. 46Choice of approved bodies and conformity assessment bodies
  111. 47General matters relating to approved bodies
  112. 47ARegister of approved bodies
  113. 48Designation etc. of ... conformity assessment bodies
  114. 49Fees charged by approved bodies and conformity assessment bodies
  115. 50Products incorrectly marked with an approved body or conformity assessment body number
  116. 51Products incorrectly marked with a UK marking
  117. Part VI: Fees charged by the Secretary of State
  118. 52Interpretation of Part VI
  119. 53Fees in connection with the registration of devices and changes to registration details
  120. 54Fees payable in connection with the designation of approved bodies
  121. 55Fees payable in connection with the designation etc. of ... conformity assessment bodies
  122. 56Fees payable in relation to clinical investigation notices
  123. 56AFees in connection with approval of coronavirus test devices
  124. 56BCircumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
  125. 56CFees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
  126. 56DFees payable in connection with pre-consultation meetings Repealed
  127. 56EFees payable in connection with regulatory advice meetings
  128. 57Unpaid fees
  129. 58Waivers, reductions and refunds
  130. 58ATime for payment of fees - small companies
  131. Part VII: General, Enforcement and Miscellaneous
  132. 59Interpretation of Part VII
  133. 60Status of UK responsible person
  134. 61Enforcement etc.
  135. 62Compliance notices Repealed
  136. 63Restriction notices Repealed
  137. 64Notification of decisions etc. Repealed
  138. 65Centralised systems of records etc.
  139. 66Revocations
  140. 67Review
  141. Signature
  142. Schedule 1: ASSOCIATION AGREEMENTS
  143. 1Paragraph 1
  144. Schedule 2: MUTUAL RECOGNITION AGREEMENTS
  145. 1Paragraph 1
  146. 2Paragraph 2
  147. 3Paragraph 3
  148. 4Paragraph 4
  149. 5Paragraph 5
  150. Schedule 2Mutual Recognition Agreement countries
  151. Schedule 2A: Modification of Annexes to Directives 90/385, 93/42, 98/79
  152. Part 1: Modification of Annexes to Directive 90/385
  153. 1Paragraph 1
  154. 2Paragraph 2
  155. 3Paragraph 3
  156. 4Paragraph 4
  157. 5Paragraph 5
  158. 6Paragraph 6
  159. 7Paragraph 7
  160. 8Paragraph 8
  161. 9Paragraph 9
  162. 10Paragraph 10
  163. Part 2: Modification of Annexes to Directive 93/42
  164. 11Paragraph 11
  165. 12Paragraph 12
  166. 13Paragraph 13
  167. 14Paragraph 14
  168. 15Paragraph 15
  169. 16Paragraph 16
  170. 17Paragraph 17
  171. 18Paragraph 18
  172. 19Paragraph 19
  173. 20Paragraph 20
  174. 21Paragraph 21
  175. 22Paragraph 22
  176. 23Paragraph 23
  177. Part 3: Modification of Annexes to Directive 98/79
  178. 24Paragraph 24
  179. 25Paragraph 25
  180. 26Paragraph 26
  181. 27Paragraph 27
  182. 28Paragraph 28
  183. 29Paragraph 29
  184. 30Paragraph 30
  185. 31Paragraph 31
  186. 32Paragraph 32
  187. 33Paragraph 33
  188. Explanatory note