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Chapter VI CLINICAL EVALUATION AND CLINICAL INVESTIGATIONSF1

United Kingdom Repealed

Original text. Later amendments are not shown.

  1. 61Clinical evaluation
  2. 62General requirements regarding clinical investigations conducted to demonstrate conformity of devices
  3. 63Informed consent
  4. 64Clinical investigations on incapacitated subjects
  5. 65Clinical investigations on minors
  6. 66Clinical investigations on pregnant or breastfeeding women
  7. 67Additional national measures
  8. 68Clinical investigations in emergency situations
  9. 69Damage compensation
  10. 70Application for clinical investigations
  11. 71Assessment by Member States
  12. 72Conduct of a clinical investigation
  13. 73Electronic system on clinical investigations
  14. 74Clinical investigations regarding devices bearing the CE marking
  15. 75Substantial modifications to clinical investigations
  16. 76Corrective measures to be taken by Member States and information exchange between Member States
  17. 77Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
  18. 78Coordinated assessment procedure for clinical investigations
  19. 79Review of coordinated assessment procedure
  20. 80Recording and reporting of adverse events that occur during clinical investigations
  21. 81Implementing acts
  22. 82Requirements regarding other clinical investigations

Annotations

Textual amendments

F1

Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4O (with savings and transitional provisions for N.I. in reg. 3ZA) (as amended by S.I. 2019/791, regs. 1(1), 3(7) and by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2; and as amended (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 4, 32); 2020 c. 1, Sch. 5 para. 1(1))