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Clinical evidence guidelines: Medical devices

24 February 2017

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Appendix 4: References

  1. For example, medical devices may be exempt from inclusion on the ARTG under Parts 4-6A and 4-7 of the Therapeutic Goods Act 1989, and under Part 7 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002

    https://www.legislation.gov.au/Details/C2016C01034/Html/Text#_Toc465840014;
    https://www.legislation.gov.au/Details/C2016C01034/Html/Text#_Toc465840022;
    https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600809;
    https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601057

  2. Australian Regulatory Guidelines for Medical Devices: https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd
  3. Therapeutic Goods Act 1989: https://www.legislation.gov.au/Series/C2004A03952
  4. Therapeutic Goods Act 1989, Chapter 4 - Medical Devices: https://www.legislation.gov.au/Details/C2016C01034/Html/Text#_Toc465839898
  5. Therapeutic Goods (Medical Devices) Regulations 2002: https://www.legislation.gov.au/Series/F2002B00237
  6. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2 - Classification rules for medical devices other than IVD medical devices: https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600933
  7. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 2A - Classification rules for IVD medical devices: https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600961
  8. TGA guidance - Classification of IVD medical devices: https://www.tga.gov.au/publication/classification-ivd-medical-devices
  9. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 1 https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600880
  10. Therapeutic Goods Act 1989, section 41FN https://www.legislation.gov.au/Details/C2016C01034/Html/Text#_Toc465839985
  11. Therapeutic Goods Act 1989, section 41JA https://www.legislation.gov.au/Details/C2016C01034/Html/Text#_Toc465840031
  12. MD Regulation 3.11(2) requires that the clinical evaluation procedures outlined in Schedule 3 Part 8 need to be applied to all medical devices, with narrow exceptions for some devices exempt from inclusion in the ARTG (such as devices imported for personal use) or those devices approved for special or experimental purposes (under Act s.41HB) or under authorised prescriber arrangements (s.41HC). https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600779; https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601038
  13. Therapeutic Goods (Medical Devices) Regulations 2002, Part 8 - Clinical evaluation procedures: https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601038
  14. MD Regulation 3.11(1) https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600779
  15. Essential Principle 4 - Long term safety: https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600885
  16. Essential Principles 13.3 (Information to be provided with medical devices - particular requirements) and 13.4 (Instructions for use): https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600929
  17. Paragraph 41BD(2) of the Therapeutic Goods Act 1989: https://www.legislation.gov.au/Details/C2016C01117/Html/Text#_Toc468263367
  18. Further reading on balancing risk and benefit is included in FDA, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, 2016. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm517504.pdf
  19. Items 3 and 4 of Essential Principle 13.4.(3): https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600930
  20. Item 19 of Essential Principle 13.4: https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600930
  21. Items 5 of Essential Principles 13.3 and 13.4.(3): https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600929
  22. Item 4 of Essential Principle 13.3 and item 7 of Essential Principle 13.4(3): https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600929 https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600930
  23. Item 26 of Essential Principle 13.4.(3): https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456600930
  24. ISO Standard 13485: Medical devices - Quality management systems - Requirements for regulatory purposes 2011: http://www.iso.org/iso/catalogue_detail?csnumber=36786
  25. ISO Standard 14155: Clinical investigation of medical devices for human subjects - Good clinical practice 2011. http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=45557
  26. ISO Standard 14971: Application of risk management to medical devices. http://www.iso.org/iso/catalogue_detail?csnumber=38193
  27. ISO 9001 is a series of standards that define, establish, and maintain a quality assurance system for manufacturing and service industries. The emphasis of ISO13485 is different, i.e., focussed on meeting national regulations rather than promoting continuous improvement and customer satisfaction.
  28. MEDDEV 2.7/1 revision 4 - Clinical evaluation: Guide for manufacturers and notified bodies http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/
  29. Conformity Assessment Standards Order (standard for quality management systems and quality assurance techniques) 2008: https://www.legislation.gov.au/Details/F2008L04337
  30. World Medical Association, Declaration of Helsinki, 2013. http://www.wma.net/en/30publications/10policies/b3/
  31. ISO Standard 11979-7: Ophthalmic implants - Intraocular lenses 2014 - Clinical Investigations:
    http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=55684
  32. ISO Standard 5840: Cardiovascular implants - Cardiac valve prostheses, 2015: http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=61732
  33. ISO/TS 10974: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device, International Organization for Standardization (2012).
  34. GHTF document, Clinical Evidence - Key Definitions and Concepts, SG5/N1R8:2007 http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n1r8-clinical-evaluation-key-definitions-070501.pdf
  35. The manufacturer must ensure that the clinical data is evaluated by competent clinical experts under MD Regulations Schedule 3 Part 8 Clause 8.6 (1) and (2) https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601038
  36. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 8, Item 8.4 (4) and (5) https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601038
  37. National Statement on ethical conduct in human research (2007) - Updated May 2015: https://www.nhmrc.gov.au/guidelines-publications/e72
  38. Note for guidance on good clinical practice (CHMP/ICH/135/95): https://www.tga.gov.au/publication/note-guidance-good-clinical-practice
  39. Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 8, Item 8.4 (5) https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601038
  40. For further details on ICMJE clinical trial registration requirements see: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration
  41. For further details on the WHO International Clinical Trials Registry Platform see: http://apps.who.int/trialsearch/Default.aspx
  42. For further details on ANZCTR see: http://www.anzctr.org.au/Support/AboutUs.aspx
  43. For further details on clinical trials see: https://www.tga.gov.au/clinical-trials#ctaust
  44. Consolidated Standards of Reporting Trials (CONSORT): http://www.consort-statement.org/
  45. Strengthening the reporting of observational studies in epidemiology: http://www.strobe-statement.org/index.php?id=strobe-home
  46. Standards for the Reporting of Diagnostic Accuracy Studies (STARD): http://www.stard-statement.org/
  47. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA): http://www.prisma-statement.org/
  48. Meta-analysis of Observational Studies in Epidemiology (MOOSE) Guidelines - http://www.consort-statement.org/Media/Default/Downloads/Other%20Instruments/MOOSE%20Statement%202000.pdf
  49. Literature reviews are required under the MD Regulations Schedule 3 Part 8 Clause 8.3 and 8.5. https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601041
  50. Database of Adverse Event Notifications (DAEN) - medical devices: https://www.tga.gov.au/DEVICES/daen-entry.aspx
  51. System for Australian Recall Actions (SARA): https://www.tga.gov.au/recall-actions
  52. Australian Breast Device Registry (ABDR): http://www.med.monash.edu.au/sphpm/depts-centres-units/abdr/
  53. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR): https://aoanjrr.sahmri.com/
  54. Victorian Cardiac Outcomes Registry (VCOR): http://www.vcor.org.au/
  55. PubMed: http://www.ncbi.nlm.nih.gov/pubmed
  56. Scottish Intercollegiate Guidelines Network (SIGN) - Critical appraisal: Notes and checklists: http://www.sign.ac.uk/checklists-and-notes.html
  57. Centre for evidence-based medicine - Critical appraisal tools: http://www.cebm.net/critical-appraisal/
  58. Cochrane Handbook for Systematic Reviews of Interventions: http://handbook.cochrane.org/
  59. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines: http://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/stage_2_consultation_levels_and_grades.pdf
  60. GHTF document, Clinical Evaluation SG5/N2R8:2007 Appendix E: A Possible Format for a Clinical Evaluation Report http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf
  61. The manufacturer must ensure that the clinical data is evaluated by competent clinical experts under MD Regulations Schedule 3 Part 8 Clause 8.6 (1) and (2) https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601044
  62. FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (Feb 2016), page 5 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/Ucm259760
  63. ISO Standard 14971:2007: Medical devices - Application of risk management to medical devices: http://www.iso.org/iso/catalogue_detail?csnumber=38193
  64. GHTF document, Clinical Evaluation SG5/N2R8:2007 http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf
  65. Therapeutic Goods (Medical Devices) Regulations 2002 - Dictionary: https://www.legislation.gov.au/Details/F2016C00755/Html/Text#_Toc456601065
  66. GHTF document, Clinical Evaluation SG5/N2R8:2007, page 8 http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf
  67. Medical Device Directive 2.4/1 Revision 9 (June 2010) Classification of Medical Devices Guidance Document, available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf
  68. Therapeutic Goods Act 1989 - Section 41MP - Criminal offence for failing to notify adverse events etc.: https://www.legislation.gov.au/Details/C2016C01034/Html/Text#_Toc465840092
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  74. United States Food and Drug Administration - Clinical Trials and Human Subject Protection: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
  75. Providing yearly figures allows the estimation of cumulative percent incidence, or incidence as a fraction of observation years. It is good practice for the Manufacturer to perform these calculations on a regular basis. For implants such as orthopaedics, Kaplan Meyer analysis is preferred. This sort of analysis is often performed with revision surgery (i.e. % requiring revision at 1, 2, 3, .., n years from the time of primary surgery as an end point, but it can also be performed on many other endpoints.
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