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Chapter VI CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIESF1

United Kingdom Repealed

Original text. Later amendments are not shown.

  1. 56Performance evaluation and clinical evidence
  2. 57General requirements regarding performance studies
  3. 58Additional requirements for certain performance studies
  4. 59Informed consent
  5. 60Performance studies on incapacitated subjects
  6. 61Performance studies on minors
  7. 62Performance studies on pregnant or breastfeeding women
  8. 63Additional national measures
  9. 64Performance studies in emergency situations
  10. 65Damage compensation
  11. 66Application for performance studies
  12. 67Assessment by Member States
  13. 68Conduct of a performance study
  14. 69Electronic system on performance studies
  15. 70Performance studies regarding devices bearing the CE marking
  16. 71Substantial modifications to performance studies
  17. 72Corrective measures to be taken by Member States and information exchange between Member States on performance studies
  18. 73Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
  19. 74Coordinated assessment procedure for performance studies
  20. 75Review of the coordinated assessment procedure
  21. 76Recording and reporting of adverse events that occur during performance studies
  22. 77Implementing acts

Annotations

Textual amendments

F1

Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4P (as inserted by S.I. 2019/791, regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9(m)); 2020 c. 1, Sch. 5 para. 1(1))