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The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

Draft. This instrument was laid in draft and may differ from the one made. Look for the made version under its title.

Draft 2020, ISBN 9780348214956

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

This draft Statutory Instrument supersedes the draft of the same title which was laid before Parliament and published on 15 October 2020 (ISBN 978-0-348-21380-5). It is being issued free of charge to all known recipients of that draft Statutory Instrument.

Draft Regulations laid before Parliament under paragraphs 1(1) and 8F(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, for approval by resolution of each House of Parliament.

Exiting The European Union

Consumer Protection

Made ***

Coming into force in accordance with regulation 1(2) and (3)

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1) and 8C of, paragraphs 1(1)(ab) and 7(2) of Schedule 4, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018f1 and section 41(1) of the European Union (Withdrawal Agreement) Act 2020f2.

A draft of this instrument has been approved by a resolution of each House of Parliament, in accordance with paragraphs 1(1) and 8F(1)f3 of Schedule 7 to the European Union (Withdrawal) Act 2018.

The Treasury has consented to the making of these Regulations as required by paragraphs 3(1) and 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.

Annotations to the whole text

Footnotes

f1

2018 c. 16. The European Union (Withdrawal) Act 2018 was amended by the European Union (Withdrawal Agreement) Act 2020 (c. 1) (“the 2020 Act”). Section 8C was inserted by section 21 of the 2020 Act, and paragraph 1(1)(ab) of Schedule 4 by section 28 of that Act. Paragraph 21 of Schedule 7 was amended by paragraph 53(2) of Schedule 5 to the 2020 Act.

f2

2020 c. 1.

f3

Paragraph 8F was inserted by paragraph 51 of Schedule 5 to the 2020 Act.

Contents

  1. 1Citation, commencement and application
  2. 2Amendment of the Medical Devices Regulations 2002
  3. 3Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
  4. 4Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
  5. Signature
  6. Schedule 1: Amendment of the Medical Devices Regulations 2002
  7. 1Paragraph 1
  8. 2Amendment of regulation 2
  9. 3Insertion of regulation 10A
  10. 4Amendment of regulation 16
  11. 5Amendment of regulation 17
  12. 6Substitution of regulation 19
  13. 7Insertion of regulation 19B
  14. 8Insertion of regulation 21B
  15. 9Insertion of regulation 24A
  16. 10Amendment of regulation 29
  17. 11Amendment of regulation 30
  18. 12Amendment of regulation 35
  19. 13Insertion of regulation 36A
  20. 14Amendment of regulation 41
  21. 15Substitution of regulation 44
  22. 16Amendment of regulation 45
  23. 17Insertion of regulation 47A
  24. 18Amendment of regulation 48
  25. 19Amendment of regulation 49
  26. 20Amendment of regulation 53
  27. 21Amendment of regulation 55
  28. 22Amendment of regulation 58
  29. 23Amendment of regulation 60
  30. 24Amendment of regulation 61
  31. 25Amendment of regulation 63
  32. 26Amendment of regulation 65
  33. Schedule 2: Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
  34. 1Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
  35. 2Amendment of regulation 1
  36. 3Substitution of regulation 3(2)
  37. 4Amendment of regulation 3(3)
  38. 5Amendment of regulation 3(4)
  39. 6Insertion of regulation 3(4A)
  40. 7Amendment of regulation 3(5)
  41. 8Amendment of regulation 3(6)
  42. 9Amendment of regulation 3(7)
  43. 10Omission of regulation 4(2)
  44. 11Amendment of regulation 4(3)
  45. 12Amendment of regulation 4(4)
  46. 13Amendment of regulation 4(6)
  47. 14Insertion of regulation 4(6A)
  48. 15Insertion of regulation 4(6B)
  49. 16Substitution of regulation 4(7)
  50. 17Insertion of regulation 4(7A)
  51. 18Insertion of regulation 4(7B)
  52. 19Insertion of regulation 4(7C)
  53. 20Insertion of regulation 4(7D)
  54. 21Substitution of regulation 4(8)
  55. 22Substitution of regulation 4(9)
  56. 23Insertion of regulation 4(10)
  57. 24Insertion of regulation 4(11)
  58. 25Amendment of regulation 5(3)
  59. 26Insertion of regulation 5(4A)
  60. 27Insertion of regulation 5(4B)
  61. 28Substitution of regulation 5(5)
  62. 29Insertion of regulation 5(5A)
  63. 30Insertion of regulation 5(5B)
  64. 31Insertion of regulation 5(5C)
  65. 32Substitution of regulation 5(6)
  66. 33Substitution of regulation 5(7)
  67. 34Insertion of regulation 5(8)
  68. 35Omission of regulation 6(2)
  69. 36Amendment of regulation 6(3)
  70. 37Substitution of regulation 6(4)
  71. 38Insertion of regulation 6(4A)
  72. 39Insertion of regulation 6(4B)
  73. 40Substitution of regulation 6(5)
  74. 41Insertion of regulation 6(5A)
  75. 42Substitution of regulation 6(6)
  76. 43Substitution of regulation 6(7)
  77. 44Insertion of regulation 6(8)
  78. 45Insertion of regulation 6(9)
  79. 46Insertion of regulation 6(10)
  80. 47Substitution of regulation 7
  81. 48Substitution of regulation 8(2) and (3)
  82. 49Insertion of regulation 8(4A)
  83. 50Amendment of regulation 8(5)
  84. 51Substitution of regulation 9(4)
  85. 52Amendment of regulation 9(5)
  86. 53Insertion of regulation 9(6A)
  87. 54Omission of regulation 10
  88. 55Omission of regulation 11
  89. 56Substitution of Schedule 2A as inserted by regulation 12
  90. 57Omission of Schedules 3 to 28 as inserted by regulation 12
  91. Explanatory note