OpenLegislation

The In Vitro Diagnostic Medical Devices Regulations 2000 (revoked)

S.I. 2000/1315 · Made 11 May 2000 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 13 June 2002.

CONSUMER PROTECTION

Made 11th May 2000

Laid before Parliament 15th May 2000

Coming into force 7th June 2000

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Annotations to the whole text

Textual amendments

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Regulations revoked (13.6.2002) by The Medical Devices Regulations 2002 (S.I. 2002/618), regs. 1, 66(f)

Contents

  1. 1Citation and commencement Repealed
  2. 2Interpretation Repealed
  3. 3Scope of the Regulations Repealed
  4. 4Essential requirements for relevant devices Repealed
  5. 5CE marking Repealed
  6. 6CE marking of relevant devices that come within the scope of more than one Directive Repealed
  7. 7Relevant devices not ready for use Repealed
  8. 8Exemptions from regulations 4, 5 and 7 Repealed
  9. 9Procedure for affixing a CE marking Repealed
  10. 10Supplemental provisions relating to conformity assessment procedures Repealed
  11. 11CE marking of a product which is not a relevant device Repealed
  12. 12Devices for performance evaluation Repealed
  13. 13Designation of authorised representatives for registration purposes Repealed
  14. 14Registration of manufacturers etc. of devices Repealed
  15. 15Designation etc. of notified bodies Repealed
  16. 16Functions of notified bodies Repealed
  17. 17Fees charged by UK notified bodies Repealed
  18. 18Enforcement etc. Repealed
  19. 19Notice procedures Repealed
  20. 20Transitional provisions Repealed
  21. 21Notification of decisions etc. Repealed
  22. 22Amendments to the 1994 Regulations Repealed
  23. 23Amendments to the 1995 Regulations Repealed
  24. Signature
  25. Schedule 1: AMENDMENTS TO THE 1994 REGULATIONS Repealed
  26. 1Paragraph 1 Repealed
  27. 2Paragraph 2 Repealed
  28. 3Paragraph 3 Repealed
  29. 4Paragraph 4 Repealed
  30. 5Paragraph 5 Repealed
  31. 6Paragraph 6 Repealed
  32. 7Paragraph 7 Repealed
  33. 8Paragraph 8 Repealed
  34. 9Paragraph 9 Repealed
  35. 10Paragraph 10 Repealed
  36. 11Paragraph 11 Repealed
  37. Schedule 2: AMENDMENTS TO THE 1995 REGULATIONS Repealed
  38. 1Paragraph 1 Repealed
  39. 2Paragraph 2 Repealed
  40. 3Paragraph 3 Repealed
  41. Explanatory note

1Citation and commencementF1

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2InterpretationF1

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3Scope of the RegulationsF1

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4Essential requirements for relevant devicesF1

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5CE markingF1

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6CE marking of relevant devices that come within the scope of more than one DirectiveF1

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7Relevant devices not ready for useF1

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8Exemptions from regulations 4, 5 and 7F1

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9Procedure for affixing a CE markingF1

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10Supplemental provisions relating to conformity assessment proceduresF1

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11CE marking of a product which is not a relevant deviceF1

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12Devices for performance evaluationF1

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13Designation of authorised representatives for registration purposesF1

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14Registration of manufacturers etc. of devicesF1

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15Designation etc. of notified bodiesF1

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16Functions of notified bodiesF1

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17Fees charged by UK notified bodiesF1

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18Enforcement etc.F1

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19Notice proceduresF1

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20Transitional provisionsF1

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21Notification of decisions etc.F1

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22Amendments to the 1994 RegulationsF1

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23Amendments to the 1995 RegulationsF1

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Signature

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Explanatory note

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .