Personalised Medical Devices FrameworkRegulatory changes to custom-mademedical devices

Bec BatesonAssistant Director, Devices Emerging Technology and Diagnostics

1 March 2021

Bec BatesonAssistant Director, Devices Emerging Technology and Diagnostics SectionMedical Devices Surveillance BranchMedical Devices and Product Quality DivisionTherapeutic Goods Administration

Today’s presentation

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• What is a medical device?• Overview of the new framework

– Changes to custom-made medical devices– Patient-matched medical devices– Adaptable medical devices– MDPSs

• FAQ• Work ahead• What to do• Resources

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What is a medical device?• Intended purpose meets the definition of a medical device under Section 41BD

of the Therapeutic Goods Act• 41BD What is a medical device

(1) A medical device is:(a) any instrument, apparatus, appliance, software, implant, reagent, material or other article

(whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:(i) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of

disease;(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or

disability;(iii) investigation, replacement or modification of the anatomy or of a physiological or

pathological process or state;and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means…

Overview

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• Custom-made medical devices exempt from inclusion in the ARTG under the Therapeutic Goods (Medical Devices) Regulations 2002

• Traditionally these devices were low risk• Rapid advances in technology have changed the regulatory environment• Public consultation and collaboration through the International Medical Device

Regulator’s Forum• A new regulatory framework for personalised medical devices commenced on

25 February 2021

Overview of the changes

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Custom-made medical devices• Majority will meet the definition of patient-matched• Continue to be exempt from inclusion in the ARTG• New obligations

– Information to be supplied with the device– Record keeping requirements

a minimum of 5 years after the date of manufacture if the device is non-implantable; or

a minimum of 15 years after the date of manufacture if the device is implantable.

– Annual reporting– Inspection and review

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Patient-matched medical devices• Manufactured within a “design

envelope”• Production processes can be

validated, verified or reproduced• No longer exempt – must be

included in the ARTG• Notify the TGA by 25 August

2021 to access transition arrangements

• Submit an application for inclusion before 1 November 2024

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Design envelope• Manufactured within a “design envelope”• Processes that can be validated, verified

and reproduced

Layman’s example: construction of windows for building versus windows for a submarine designed to visit the bottom of the Mariana Trench

Clinically: the difference between designing a medical device for most people versus Andre the giant (2.24 metres tall, 236 kilos and unusually large musculature)

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Adaptable medical device• A new definition for an existing concept• Mass-produced and designed to be modified at the point of care to suit

a particular patient.• Definition introduced to provide clarity• Adaptable medical devices continue to

require inclusion in the ARTG before they can be supplied.

• Essential principle 13.4(3) will specifically require adaptable medical devices are supplied with instructions to allow safe modification/assembly at the point of care.

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Medical Device Production System• A validated, multi-

component design and production system

• Included in the ARTG• Supplied by a

manufacturer to health professionals and healthcare facilities

• Produces a specific type of patient-matched medical device in-house

Medical Device

Production System

Raw materials

DesignManufacturing equipment

Patient-matched

device

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MDPS Continued• COMING SOON – definition commenced 25 February but there’s more work to

be done• Health professionals (or a suitably qualified person within a healthcare facility)

who use an MDPS to produce a medical device will not need to meet all the regulatory obligations of a manufacturer.

• Examples of conditions of use:– In accordance with the intended purpose of

the MDPS– MDPS used in accordance with the Instructions

For Use– Report adverse events– Maintain patient records

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FAQs• Is my product a medical device?

• Am I the manufacturer or the sponsor?

• What do I need to do?

• What classification is my device?

• How much does it cost?

• What is the design envelope?

• What is validation and verification?

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Work ahead• Communication and education

– Regulatory basics– Frequently asked questions– Sector-specific content (particularly

regulatory boundaries)– Engagement with peak groups– Engagement with allied health– Direct engagement via subscriber

list– Videos– Webinars

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If you are the manufacturer / sponsor• Read the personalised medical devices guidance

• Subscribe to receive updates (send an email to devices@health.gov.auwith “SUBSCRIBE PMD” in the subject line

• Submit a custom-made medical devicenotification

• Register for transition by 25 August 2021

• For custom-made devices and devices transitioning to ARTG inclusion –submit your first annual report by 1 October 2021

• For patient-matched – submit your application for inclusion by 1 November 2024

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If you are not the manufacturer / sponsor

If you procure the device from an Australian supplier, you will need to check that they are aware of the changes and are planning to include the device in the ARTG.

Please encourage your supplier to send an email to devices@health.gov.auwith “SUBSCRIBE PMD” in the subject line so they receive information and updates to support them with meeting their regulatory requirements.

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Resources and contacts• Medical device inclusion process guidance

• Essential principles checklist

• Declaration of conformity templates

• Comparable overseas regulators

• Send an email to devices@health.gov.auwith “SUBSCRIBE PMD” in the subject line

• Medical devices information unit

o 1800 14 11 44

o devices@tga.gov.au

• SME Assist

• Regulatory affairs consultants