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Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019

10 January 2020

Overview

The Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) were amended on 12 December 2019.

This is the first package of regulatory changes for the broader medical device reforms and follows a number of public consultations which occurred late 2018 through early 2019.

Some key issues raised during consultation require further engagement with stakeholders and further regulatory changes will follow in mid to late 2020.

An overview of changes is provided below and detailed guidance will be made available.

Software

Regulation of software will continue to be risk and principles based.

What's changing

The Regulations have been amended in relation to software-based medical devices including programmed and programmable hardware (referred to collectively as 'programmed or programmable medical device, or software that is a medical device'):

  • New classification rules have been introduced to classify devices of this kind according to their potential to cause harm through the provision of incorrect information.
    • The rules are largely aligned with the software rules in the EU MDR 2017
    • In some cases, a device will be a lower classification (where a relevant healthcare professional is involved);
    • Devices that provide direct diagnosis or monitoring will be the same class in most cases.
    • Devices intended to provide therapy via the provision of information (e.g., a medical device intended to provide cognitive behavioural therapy) will potentially be a higher class in some cases.
    • The new classification rules will not apply to in vitro diagnostic (IVD) medical devices.
  • Essential principle 12.1 has been amended to clarify the expectations around these types of devices, including with regards to cyber security; the management of data and information; and requirements relating to development, production, and maintenance.
  • Essential Principle 13.2(3) has been amended to allow information, where applicable, to be provided electronically rather than on a leaflet for medical devices that are software.
  • A new requirement has been introduced, as Essential Principle 13B, for identification of current version and build number to be made accessible by, and identifiable to, users of medical devices that are, or that incorporate, software. 

Further guidance will be provided in early 2020.

Important dates

The new software regulations will commence on 25 August 2020 for new applications for inclusion.

Transitional arrangements for medical devices that are included in the ARTG on this date will apply.

Personalised medical devices

What's changing

Regulatory changes have been introduced that:

  • Reduce the scope of the existing definition of custom-made medical device.
  • Introduce new definitions in relation to personalised medical devices; and
  • Change the exemption requirements for custom-made medical devices to:
    • require annual reporting of custom-made devices supplied in the previous financial year;
    • allow the TGA to inspect production facilities;
    • require documentation about the device to be retained for 5 years (for non-implantables) or 15 years (for implantables); and
    • require manufacturers to provide information about each custom-made medical device to the intended recipient
  • Introduce a new concept of Medical Device Production System (MDPS) and a framework for regulating medical device production systems which will allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification. An MDPS will have the same classification as the medical device the system is intended to create.
  • Update the classification rule 5.4 for medical devices that record diagnostic images so that it includes non-visible spectrum imaging mechanisms for this purpose and not just X-rays, and also includes models of patient anatomy. The effect of this will be that some devices will be Class IIa rather than Class I after the change.

Further guidance will be provided in the following months.

Important dates

The new personalised medical device regulations will commence on 25 August 2020.

For those custom-made devices that will be patient-matched medical devices under the new definition, transitional arrangements will apply.

Similarly, transitional arrangements will apply in relation to medical devices that record diagnostic images and that are anatomical models.

IVD companion diagnostics

What's changing

The regulations have been amended to further align with the USFDA and EU with respect to the devices known as "IVD companion diagnostics". Under the changes a definition of "IVD companion diagnostic" will be included in the Regulations identifying these devices based on their use in the selection of patients for selective therapy and management. Products that meet the definition will be regulated as Class 3 IVDs and will be required to undergo compulsory audit.

Important dates

For IVD companion Diagnostics seeking inclusion and a new application is received on or after the 1 February 2020 the new rules apply.

Transitional arrangements apply to IVD companion diagnostics that, on 31 January 2020:

  • are included in the ARTG; or
  • are the subject of an effective application for inclusion in the ARTG that has not been finally determined; or
  • are not included in the ARTG but are covered by a current conformity assessment certificate issued by the TGA; or
  • are not included in the ARTG but are covered by an effective application for a conformity assessment certificate that has not been finally determined; or
  • are in-house IVDs that are Class 1, Class 2 or Class 3 (noting that IVD companion diagnostics will be Class 3 under the new Regulations but Class 1-3 in-house IVDs are exempt from inclusion in the ARTG).

A new application for inclusion that complies with the amended Regulations must be made before 30 June 2022 (for commercially supplied IVD companion diagnostics).

Draft guidance on IVD companion diagnostics is now available at: IVD Companion Diagnostics: Guidance on proposed regulatory requirements

Reclassification of devices

Device area Overview Current state Future state

Spinal implantable medical devices

Implantable devices that are intended to be a motion-preserving device for the spine or that come into contact with the spinal column will be reclassified from Class IIb to Class III.

Spinal fusion implantable devices, such as screws, cages, plates, hooks or rods that are used during spinal fusion surgical procedures, will remain classified as Class IIb.

Implantable devices that are intended to be a motion-preserving device for the spine or that come into contact with the spinal column are currently classified as Class IIb.

Spinal fusion implantable devices are currently classified as Class IIb.

Implantable devices that are intended to be a motion-preserving device for the spine or that come into contact with the spinal column will be classified as Class III.

Spinal fusion implantable devices will remain classified as Class IIb.

All spinal implantable medical devices must be selected for an application audit.

Active medical devices for therapy with diagnostic function

Devices intended to significantly determine patient management by the device (e.g. closed loop systems or automated external defibrillators) will be reclassified from Class IIa/Class IIb to Class III.

Currently Class IIa/Class IIb.

Reclassified to High Risk Class III.

Note: It is intended that continuous positive airway pressure (CPAP) machines will remain Class IIb.

Active implantable medical devices and their accessories

Active implantable medical devices (AIMD) and long-term surgically invasive and implantable accessories to AIMD will be classified as Class III.

Active implantable medical devices are currently classified as Class AIMD.

Class III

Medical devices that administer medicines or biologicals by inhalation

All invasive medical devices intended to administer medicines or biologicals by inhalation will be classified as Class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered therapeutic good or they are intended to treat life-threatening conditions, in which case they will be classified as Class IIb.

Class I or Class IIa

Class IIa or ClassIIb

Medical device that consist of substances introduced into the body via a body orifice or applied to the skin

Devices composed of substances, or combinations of substances, that are intended to be introduced into the human body through an orifice or applied to the skin, and to be absorbed by, or locally dispersed, in the human body after introduction or application will be classified as either Class III, Class IIa or Class IIb, consistent with rule 21 of Chapter III of Annex VIII of EU Regulation 2017/745.

Class I – Class IIa

Class IIa. Class IIb or ClassIII

Medical devices used in direct contact with the heart, central circulatory or central nervous systems

Surgically invasive medical devices intended for use in contact with the heart, CCS or the CNS will be classified as Class III (high risk) medical devices.

Class IIa

Class III

Important dates

New classification rules will apply to all new applications for ARTG inclusion from 25 August 2020.

Transitional arrangements apply to devices that are:

  • already included in the ARTG as at 25 August 2020; or
  • are the subject of an application for inclusion in the ARTG submitted to the TGA prior to 25 August 2020 and the application fee has been paid.

Further information and guidance about the new classification rules and transitional arrangements will be available in early 2020.