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The In Vitro Diagnostic Medical Devices Regulations 2000

Status:

This is the original version (as it was originally made).

  1. Introductory Text

  2. 1.Citation and commencement

  3. 2.Interpretation

  4. 3.Scope of the Regulations

  5. 4.Essential requirements for relevant devices

  6. 5.CE marking

  7. 6.CE marking of relevant devices that come within the scope of more than one Directive

  8. 7.Relevant devices not ready for use

  9. 8.Exemptions from regulations 4, 5 and 7

  10. 9.Procedure for affixing a CE marking

  11. 10.Supplemental provisions relating to conformity assessment procedures

  12. 11.CE marking of a product which is not a relevant device

  13. 12.Devices for performance evaluation

  14. 13.Designation of authorised representatives for registration purposes

  15. 14.Registration of manufacturers etc. of devices

  16. 15.Designation etc. of notified bodies

  17. 16.Functions of notified bodies

  18. 17.Fees charged by UK notified bodies

  19. 18.Enforcement etc.

  20. 19.Notice procedures

  21. 20.Transitional provisions

  22. 21.Notification of decisions etc.

  23. 22.Amendments to the 1994 Regulations

  24. 23.Amendments to the 1995 Regulations

  25. Signature

    1. SCHEDULE 1

      AMENDMENTS TO THE 1994 REGULATIONS

      1. 1.In regulation 2(1) of the 1994 Regulations (interpretation)—

      2. 2.In regulation 3(2) of the 1994 Regulations (application of the...

      3. 3.After regulation 12 of the 1994 Regulations (general provisions relating...

      4. 4.In regulation 14 of the 1994 Regulations (registration of persons...

      5. 5.In regulation 16 of the 1994 Regulations (clinical investigations)—

      6. 6.In regulation 17 of the 1994 Regulations (notified bodies), after...

      7. 7.For paragraph (1) of regulation 18 of the 1994 Regulations...

      8. 8.(1) In paragraph (3) of regulation 19 of the 1994...

      9. 9.After regulation 19 of the 1994 Regulations there shall be...

      10. 10.In paragraph (1) of regulation 22 of the 1994 Regulations...

      11. 11.In paragraph (1) of regulation 23 of the 1994 Regulations...

    2. SCHEDULE 2

      AMENDMENTS TO THE 1995 REGULATIONS

      1. 1.In regulation 2 of the 1995 Regulations (interpretation)—

      2. 2.After regulation 6 of the 1995 Regulations (withdrawals) there shall...

      3. 3.In the Table set out in the Schedule to the...

  27. Explanatory Note

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