Session B19: Regulatory updates from the TGA Medical Devices Branch – Part 2

Dr Elizabeth McGrathDirector, Medical Device Emerging Tech | Medical Device Reform Program

Mimi Chu-GourlayAssistant Director, Medical Devices Reforms Unit, Medical Devices Branch

7 August 2019

Overview - Part 2

• The Regulation of Software including Software as a Medical Device• Proposed Regulatory Scheme for Personalised Medical Devices, including

3D Printed Devices• Proposed changes to the Essential Principles, • Proposed changes to the Conformity Assessment Procedures,• Proposed changes to the Requirements for Devices used in Clinical Trials, • Clarifying the Requirements for Systems and Procedure Packs

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Review of Medicines and Medical Devices Regulation (MMDR)• Government accepted Recommendation 20:

The regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) framework, including in respect of the classification of medical devices and essential principles/requirements.

• Consultations closed:– The Regulation of Software including Software as a Medical Device– Proposed Regulatory Scheme for Personalised Medical Devices,

including 3D Printed Devices

• Consultations to be published:– Proposed changes to the essential principles, – Proposed changes to the conformity assessment procedures,– Proposed changes to the requirements for devices used in clinical trials, – Clarifying the requirements for systems and procedure packs 2

Closed Consultations

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Regulation of software, including SaMDSoftware is regulated by the TGA…• When it is part of a hardware medical device or system• When it controls a medical device• When it meets the definition of a medical device.

The world has changed since the Medical Device regs were written in 2002• The internet is faster and ubiquitous• High powered pocket computers• Super computers as a service• Connectivity of medical devices• Etc.

Today’s medical device software wasn’t considered in 2002 Presentation title 4

Proposals for software reform• New rules to appropriately classify Software

products according to the potential harm they could cause to patients

• Exclude Software products from the personal importation provisions so that SaMD products will be required to be included in the ARTG and have an Australian sponsor

• Ensure the essential principles for medical devices include clear and transparent requirements for demonstrating the safety and performance of software.

https://www.tga.gov.au/consultation/consultation-regulation-software-including-software-medical-device-samd5

Consultation on Software Reforms• Consultation 14 February to 31 March 2019• 41 Submissions, broad support for the proposals• Revised proposals based on feedback• Stakeholder workshop 24 June 2019 for

additional feedback

Next steps• Policy approval• Drafting, approval and publication of regulations• Identify carve outs for certain software categories• Stakeholder engagement and education• Regulatory guidance for new legislation 6

Regulation of Personalised Medical Devices (PMD)Current PMD regulation by the TGA:

The world has changed since the Medical Device regs were written in 2002• Advances in imaging and manufacturing technologies combine to make

PMD available on industrial scales

Custom-made devices are not subject to third party pre-market review7

Proposals for PMD reforms1. Introduce new definitions for personalised medical devices2. Change the requirements for supplying custom-made medical devices

in Australia, so that additional information must be provided to the TGA and to patients and, to allow the TGA to inspect manufacturing sites

3. Introduce a framework for regulating a medical device production system which will allow healthcare providers to produce lower risk personalised devices for treating their patients, without the need for manufacturing certification

4. Update the classification rule for medical devices that record diagnostic images so that it includes any device for this purpose and not just X-rays, for example 3D-printed models of patient anatomy

5. Regulate medical devices with a human origin component, for example a 3D-printed implant incorporating cells from the patient, as medical devices with a biological component rather than as pure biologicals, and

6. Clarify that any modifications or adaptations to personalise a medical device that has already been supplied must have been intended by the original manufacturer of the device.

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New Definitions for Personalised Medical Devices

• Aligned with new IMDRF definitions

• Australia led the IMDRF work

Presentation title 9

Consultation on PMD Reforms• Consultation 14 February to 31 March 2019• 24 Submissions, broad support for the proposals• Prior consultation in 2017 and 2018• Revised proposals based on feedback

Next steps• Policy approval• Drafting, approval and publication of regulations• Stakeholder engagement and education• Regulatory guidance for new legislation

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Consultations on the horizon

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Proposed Essential Principles ReformsChanges to medical device Essential Principles

All medical devices to be supplied in Australia, need to demonstrate compliance with safety and performance requirements referred to as Essential Principles.

Current requirements lack clarity, detail and do not adequately cover requirements regarding the advancements in medical technology sector such as software and other complex systems and information required for appropriate use of the device for the intended purpose by the user.

Reform Intent – Introduce revised set of Essential principles that are clear and harmonised with international requirements to ensure greater regulatory compliance and enhanced safety and performance of medical devices.

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Key Proposals for Essential Principles Reform

• Incorporate new requirements specified in the IMDRF Essential Principles for medical device safety and performance and IMDRF Principles for Labelling of medical device and additional requirements in EU MD and IVD regulations.

• Clarification of existing requirements related to public health and safety, human factors and management of medical device data and information.

• Restructure of the Australian Essential Principles through adoption of the IMDRF document structure.

NEXT STEPS – Public consultation paper to be released soon…

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Proposed System and Procedure Pack ReformsClarification of Requirements for Systems and Procedure PacksA system or procedure pack (SOPP) is a package containing therapeutic goods put together for use as a unit either in combination as a system or for use in a medical or surgical procedure.

Current requirements lack clarity regarding the conformity assessment pathways requirements such as ambiguity in conformity assessment pathway used for medical devices with special purpose.

External Workshop conducted:Feedback on issues obtained from participants - included representatives from Industry, hospitals and consumer health forums

Reform Intent– Introduce reforms that provide greater clarity to ensure regulatorycompliance to improve safety and performance of medical devices.

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Key Proposals for System and Procedure Packs

• Introduction of separate new definitions – system and procedure pack

• Clarification of requirements for medical devices to be used for special purpose– the requirement that the manufacturer of a SOPP must obtain conformity assessment document from

the TGA, a comparable overseas regulator or assessment body, from the manufacturers of each medical device they put into the SOPP.

– if the manufacturer of a SOPP intends to open or modify the packaging of any goods when these goods are put into the SOPP, the manufacturer of the SOPP must have a written agreement, with the manufacturers of the respective goods they unpackage, that will allow validation that such a production step does not impact on the performance of the goods.

NEXT STEPS – Public consultation paper to be released soon…

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Proposed Conformity Assessment Procedure Reforms

Changes to medical device Conformity assessment procedures

All medical devices to be supplied in Australia, must apply minimum applicable conformity assessment procedures and have appropriate documentation to demonstrate compliance of the medical device with the relevant essential principles.

Current procedures do not cover sufficient detail of assessment based on the risks related to device design and manufacture, particularly in areas of advancing medical technology including custom made medical devices.

Reform Intent – Introduce changes to conformity assessment procedures and revised conformity assessment pathways to reduce ambiguity and increase transparency and robustness of assessment.

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Key Proposals for Conformity Assessment Procedures

• Different conformity assessment pathways for certain devices and increased scrutiny in assessment of technical documentation for certain implantable devices to ensure risk based regulatory oversight. For example: Class IIb implantable to now require individual product assessment, to ensure appropriate scrutiny of safety and performance.

• Introduction of standardised technical documentation format and reinforcement of the rules on clinical data and clinical studies for medical devices to ensure the data requirements are clear and transparent.

• Increase in retention period for medical devices records, ensures the availability of information that will enable appropriate use of the device, and allows manufacturers to perform investigations when required.

NEXT STEPS – Public consultation paper to be released soon…

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Proposed Medical Device Clinical Trial Reforms

Requirements for Medical Devices used in Clinical Trials

TGA is responsible for regulation of import, export and/or supply of medical devices for use in clinical trials in Australia under the Therapeutic Goods Act 1989.

Current procedures do not provide for adequate oversight of the adequacy of device pre-clinical testing for high risk medical devices used in the clinical trials.

Reform Intent – Introduce changes to regulation of clinical trials to have appropriate regulatory oversight based on the potential risks of the device to ensure safety of Australian Clinical trial participants.

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Key Proposal for Medical Devices used in a Clinical Trial

For a medical device to be supplied in Australia, the device needs to meet relevant EssentialPrinciples (EPs).

Compliance with EPs:Pre-clinical testing + Clinical evaluation

Need for review of pre-clinical safety databefore human testing

Proposal: High risk implantable devices required to undergo assessment and approval by TGA through the CTX pathway, consistent with the international requirements

NEXT STEPS – Public consultation paper to be released soon…19

Further information• Medicines and Medical Devices Regulation (MMDR) Review hub:

https://www.tga.gov.au/hubs/mmdr

• Subscribe to TGA’s consultations email list: https://www.tga.gov.au/tga-consultations-email-list

• Contact the TGA Medical Devices Branch: devices@tga.gov.au ph: 1800 141 1444• Contact the TGA Device Reforms Unit: devicereforms@tga.gov.au

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