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Submissions received: Draft clinical evidence guidelines - Medical devices

16 November 2016

Overview of submissions

Key recurring themes of submissions included:

  • Seeking further clarification of language and roles, such as the roles and responsibilities of sponsor and manufacturer, clinical experts, etc.
  • The scope of the document scope, such as coverage of conformity assessment, inclusion in the ARTG and post market, and the coverage of IVDs.
  • A range of specific issues, such as the appropriateness of randomised clinical trials in the context of medical devices, MRI safety, etc.
  • The structure of Clinical Evaluation Report and additional supporting documents, in context of broader submission dossiers.

Submissions were received for 24 organisations or individuals. Seventeen provided consent for publication and are available below.

A B C F I J M N R S

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A

Respondent Response summary
Consultation submission: AusBiotech (pdf,144kb) Expresses support for the development of the guidelines with regards to its scope. Specific feedback on the utility of the document, seeking clarification on clinical expert, authoring of the CER and substantial equivalence, and suggestions for future development.
Consultation submission: Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine (pdf,355kb) Expresses support for both intent and content of the guidance document. The submission notes the difficulties of randomised controlled trials for medical devices and resulting importance of post market monitoring for a device's lifespan, emphasising the value of registries, and noting there is no current registry for implantable pain-relieving devices.

B

Respondent Response summary
Consultation submission: British Standards Institution (BSI) (pdf,47kb) BSI provided an analysis of the draft guidelines against the European requirements. The submission noted that alignment is quite close, with specific advice on where differences occur.
Consultation submission: BUPA (pdf,30kb) Outlines concerns about scope of current clinical evidence expectations, such as in relation to the use of literature reviews, recognition of substantial equivalence and the comparable efficacy of medical devices. Recommends clinical evidence (on the actual device) be the primary focus for the justification for the listing of new devices, unless there are clear and compelling reasons justifying a lower benchmark. When assessing the benefits of a device, we believe there should be explicit consideration of the outcomes of a "do nothing" option.

C

Respondent Response summary
Consultation submission: Commercial Eyes Pty Ltd (pdf,262kb) Suggests guidance document be consolidated into the ARGMD, and duplicated material in Chapter 6 be edited and repetition removed.
Consultation submission: Cook Medical (pdf,567kb)* Supportive of creation of the guidance, and provided a number of substantive suggestions for clarification, improvement or correction of the document.

F

Respondent Response summary
Consultation submission: Faculty of Pain Medicine and Australian and New Zealand College of Anaesthetists (pdf,355kb) Expresses support for both intent and content of the guidance document. The submission notes the difficulties of randomised controlled trials for medical devices and resulting importance of post market monitoring for a device's lifespan, emphasising the value of registries, and noting there is no current registry for implantable pain-relieving devices.

I

Respondent Response summary
Consultation submission: IVD Australia (pdf,742kb)* Notes that IVDs are intended to be covered by the Guidance, and notes that clinical evidence requirements for IVDs can vary from the requirements for other medical devices. Provides specific feedback on how issues relevant to IVDs might be included.

J

Respondent Response summary
Consultation submission: Johnson & Johnson Medical Pty Ltd (pdf,613kb)*

Supportive of global harmonisation efforts, particularly continued alignment of Australian and European Union requirements. Also raises a number of specific edits and corrections.

M

Respondent Response summary
Consultation submission: Medical Technology Association of Australia (MTAA) (pdf,335kb) Provided specific feedback on issues including coverage of IVDs, the role of clinical experts, supporting documents, alignment with the Medicines and Medical Devices Review, randomised controlled trials, clinical quality registries, MRI safety, use of patient cards for implantable devices, and image artefact issues.
Consultation submission: Medical Technology Association of Australia Joint Working Group (MTAA JWG) (pdf,735kb)* Provides detailed feedback on clinical evidence requirements and MRI labelling for AIMDs.
Consultation submission: Medtronic Australasia Pty Ltd (pdf,215kb) Provided extensive detailed comments, feedback and suggestions on the draft guidance. This covered the general clinical evidence requirements (outlined in Chapters 1-5) as well as specific requirements for high risk product categories outlined in Chapter 6.
Consultation submission: Monash University School of Public Health and Preventive Medicine (pdf,19kb)

Notes the importance of post-market data in medical device regulation, and the importance of registries in this context.

Also raises specific issues on cardiac and deep brain stimulation devices.

N

Respondent Response summary
Consultation submission: Name withheld (pdf,80kb) Feedback on the utility of the document (scope, structure, expression, readability etc.)
Consultation submission: NSW Therapeutic Advisory Group (NSW TAG) (pdf,107kb) Raises issues on evaluation of devices which are associated with medicine use and/or administration or contain medicines. Recommended post market pharmacovigilance monitoring of devices incorporating a medicine.

R

Respondent Response summary
Consultation submission: Royal Australian and New Zealand College of Ophthalmologists (RANZCO) (pdf,145kb) Expressed concern about cost recovery arrangements for regulatory oversight limiting development of and access to innovative products. Also concerned that 'user pays' system puts TGA in a conflicted state where the applicants are also the source of revenue.
Consultation submission: Royal Australian and New Zealand College of Radiologists (RANZCR) (pdf,208kb) Provided feedback in relation to exposure of medical devices, particularly active implantables, to magnetic resonance imaging (MRI) in relation to both TGA assessment and practical issues in clinical practice. Supports maintaining pre market clinical evidence/data requirements. Recommends development of a formal cardiac devices registry.

S

Respondent Response summary
Consultation submission: Stellar Consulting (pdf,88kb)

Notes that IVDs are intended to be covered by the Guidance, and notes that clinical evidence requirements for IVDs can vary from the requirements for other medical devices.

Suggests specific discussion on the relevance of the document to IVDs be included.