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TGA presentation: Hunter New England Local Health District 3D Printing Forum, 30 March 2019
Presentation: Current Regulatory Landscape for Medical Device 3D-Printing
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
- Presented by: Elizabeth McGrath
- Presented at: Hunter New England Local Health District 3D Printing Forum
- Presentation date: 30 March 2019
- Presentation summary: This presentation covers the Australian regulatory landscape for medical device 3D-printing and proposed reforms to this framework.
Current Regulatory Landscape for Medical Device 3D-Printing
Director, Medical Device Reforms and Emerging Technology
Hunter New England Local Health District 3D Printing Forum, 30 March 2019
Thank you for your interest in the regulation of 3D-printed medical devices. My name is Elizabeth McGrath, and I'm the director of medical device reforms and emerging technology at the TGA.
Slide 1 - Medical device 3D printing - This talk
- Overview of medical device regulation - including mass produced 3D-printed devices
- Current regulation of 3D-printed medical devices made for a particular patient
- Consultation for regulatory reforms
- International harmonisation
- Next steps
What I would like to cover in this talk is the scope of products that medical device regulation applies to; I'd like to give you an overview of the way medical devices are regulated in Australia; I'll talk about the current regulation of 3D-printed medical devices when they're made for a particular individual; I'll let you know about a consultation for some regulatory reforms that's underway; I'll talk about some international harmonisation efforts; and the next steps that we will be taking here at the TGA.
Slide 2 - Medical device 3D-printing - Scope
- Test beds for Medicine Preclinical Testing and Research
- Anatomical Models for Teaching
- Anatomical Models for Investigation of a Patient's Anatomy
- Externally Applied Medical Devices
- Invasive Medical Devices
- Implantable Medical Devices
Products that are included within the medical device regulatory framework (when they're 3-D printed - or even when they are not), but 3D-printed products that are included in the framework are anatomical models for investigation of a patient's anatomy; externally applied medical devices, such as orthotics; invasive medical devices, such as surgical tools or guides; and implantable medical devices. When 3D-printers are used to make tissue samples for testing medicines, these are not regulated as medical devices (medicines are obviously out of scope); and anatomical models where they are used for teaching or training purposes are also not regulated as medical devices.
Slide 3 - Medical device regulatory framework in Australia (including mass-produced 3D-printed devices)
Now I'll give you an overview of the current regulatory framework for medical devices here, and this includes 3D-printed medical devices which are mass produced.
Slide 4 - Regulatory requirements for medical devices
- Does it Fit the Definition of a Medical Device?
- Apply the Classification Rules
- Evidence of Safety, Performance and Quality
- Regulatory Review of Evidence (if device is above Class I)
- Manufacturing Certification (if device is above Class I)
- Inclusion in the ARTG
- Post-Market Requirements
- Monitor Post-Market Performance
- Report Problems to the TGA
- Annual Manufacturing Inspections
There are seven key steps you must undertake if you want to supply a medical device in Australia.
First, you have to determine if your product actually is a medical device, then you must apply the classification rules, you need to generate evidence for the device's safety and performance and it's quality; you will have to undergo a regulatory review of this evidence unless the device is Class I; you will also be required to get manufacturing certification, again, if the device is above Class I; you need to include your medical device in the Australian Register of Therapeutic Goods; and you'll have to comply with post-market requirements for monitoring the performance of your device and reporting any problems to the TGA; you'll also be subject to ongoing manufacturing inspections-usually on an annual basis.
Slide 5 - What is a medical device?
Defined in s41BD of the Therapeutic Goods Act 1989
Any instrument, apparatus, appliance, material or other article intended to be used for human beings for the purpose of one or more of the following
(i) diagnosis, prevention, monitoring, 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 process
(iv) control of conception;
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
Our Therapeutic Goods Act has a definition of what a medical device is: basically, it can be anything if it's intended to be used for diagnosis, prevention, monitoring, treatment, or alleviation of a disease, disability, or injury; or if it's to be used for investigation, replacement, or modification of the anatomy… so it's a pretty broad definition.
Slide 6 - Regulatory oversight increases with risk category
Low risk to high risk
- Class I
- Class IIa
- Class IIb
- Class III
Now, our oversight increases with the increasing risk category of the device, so we have rules in our regulations that help you classify your device, and this is according to its potential to cause physical harm. So, the devices that are classified as the lowest risk, Class I, are self-certified and self-declared-we do not do any pre-market assessment of these products… we always reserve the right to do assessment of products but, as a rule, we do not look at Class I devices before they are marketed. Class III get the highest level of scrutiny, where a full design examination of the medical device will be required.
Slide 7 - Some exceptions
- Special Access Scheme for Unapproved Goods
- Experimental Product Exemptions
- Custom-Made Medical Devices
- In-House In Vitro Diagnostic Devices
There are some exceptions to the requirements that I've just talked about, and the need to Include the device in the Australian Register of Therapeutic Goods; so we have a special access scheme to allow patients to gain access to products that they really are in need of but that are not yet approved in Australia; we have exemptions for experimental products used in clinical trials; custom-made medical devices are exempt from being Included in the register; and laboratory developed in-house in vitro diagnostic tests, such as those used in hospital labs, are exempt from being Included in the register
Slide 8 - Medical device regulatory framework in Australia (3D-printed devices - excluding mass-produced)
Now I'll talk about the framework that applies to 3D-printed devices when they are intended for a particular individual.
Slide 9 - Custom-made medical device
the Regulations define a custom-made medical device as …
Custom-made medical device means a medical device that:
- (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and
- (b) is intended:
- (i) to be used only in relation to a particular individual; or
- (ii) to be used by the health professional to meet special needs arising in the course of his or her practice.
Currently, we have a definition for custom-made medical device in the regulations, and if you read it, you can see that it's any medical device when it's made at the request of a health professional, and it's intended to be used for a particular individual… so this, again, is a very broad definition and any of these 3-D printed devices, when they are requested by a healthcare professional, and they rely on patient's CT scans, MRI scans, these all fit under the current definition of custom-made.
Slide 10 - Custom-made medical devices
- Exempt from Inclusion in the Australian Register of Therapeutic Goods
- Sponsors and/or Manufacturers must notify the TGA that they are supplying devices in Australia
- No third-party oversight of manufacturing or device EP compliance evidence
Now, custom-made devices, as I've mentioned, are not required to be included in the ARTG: so there's no pre-market assessment of these products. The only requirement is that sponsors in Australia, or sponsors of overseas manufacturers, must notify the TGA that they're supplying custom-made devices; so there is no third-party oversight of the evidence of quality, safety, and performance or of the manufacturing.
Slide 11 - Are consumers protected under these requirements?
- Custom-made implants are not currently subject to third-party pre-market review of safety, quality and performance
- Historically, custom-made medical devices were considered to comprise low-risk products, or be very limited in number
- High-risk devices, e.g., implants, that are manufactured conventionally are subject to rigorous regulatory oversight of design and manufacture
- There are some novice players with limited awareness of QMS and regulatory requirements involved in 3D-printed device development
So are consumers protected under these requirements? Well, historically, custom-made devices on the exemption were anticipated to be applied to low-risk products or, in more exceptional cases, to high-risk products; however, the technology that's emerging today-especially 3-D printing-is allowing increasing high-risk devices to be manufactured easily for a particular patient, and these are being supplied under these custom-made exceptions… so, potentially, not as originally intended.
Slide 12 - Regulatory reform ahead
To address this potential mismatch in the oversight of custom-made devices, we are seeking to undertake some regulatory reforms.
Slide 13 - Public consultation
- Same proposals previously consulted at the end of 2017
- Includes further detail to clarify proposals
- Seeks to understand impact on stakeholders
Before we can change our regulations, we have to go out and consult with the public. We do have a current consultation paper that's available for submissions; however, it does close on March the 31st. Now, the proposals in this paper were previously put out to the public at the end of 2017; however, the submissions requested further detail and explanation for some of these, and that's what we have done in this paper-we've sought to clarify those questions and, also, we are seeking to understand what impact these changes will have on stakeholders.
Slide 14 - Current consultation proposals
Proposal 1 - Introduce new definitions
- Personalised medical device
- Patient-matched medical device
- Adaptable medical device
Proposal 2 - Change the requirements for supplying custom-made medical devices
- Annual reporting to the TGA
- Provide information about the device to patients
- Allow the TGA to inspect manufacturing sites
Proposal 3 - Introduce a 'medical device production system'
- Allow healthcare providers to produce lower-risk personalised devices for treating their patients, without the need for manufacturing certification
The current consultation has the following proposals: First, we are proposing to introduce new definitions, and these new definitions will be for a personalised medical device; for a patient-matched medical device; and for an adaptable medical device. So, these are sort of subsets of custom-made devices but we really feel like these should probably be regulated as main-stream medical devices and not under the custom-made exemption.
Proposal two is to change the requirements for supplying custom-made medical devices so that there is annual reporting to the TGA; so that we have better oversight of these products; that patients get information about the custom-made nature of their device; and to also allow the TGA to inspect manufacturing sites for custom-made devices.
We are also proposing to introduce a medical device production system. This is defined in the paper as a collection of goods that's intended to produce a medical device at the point of care, and includes the actual medical device, so the regulation will be applied to the manufacturer of the system, and not to the user of the system. This will allow healthcare providers to provide lower risk personalised medical devices for treating patients without the need for manufacturing certification.
Slide 15 - Current consultation proposals
Proposal 4 - Update the classification rule for medical devices that record diagnostic images.
- Includes any device for this purpose and not just X-rays, for example, 3D-printed models of patient anatomy
Proposal 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.
Proposal 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.
Proposal four is to update the classification rule for medical devices that record diagnostic images, so this will capture anatomical models that are used to investigate a patient's anatomy. So our current rule was based on x-rays but obviously technology has progressed since the time that rule was put into force.
Our fifth proposal is that medical devices that contain a human-origin component, for example, 3-D bio-printed implants, should be regulated as medical devices with a biological component rather than as a pure biological; so, under current framework anything with human material is considered to be a purely biological product, however, we feel these products probably sit better under the medical device regulatory framework.
Proposal six is to clarify that any modifications or adaptations to personalise a device (so, if you need to shape or form or fit a device that has already been supplied, it has to be clearly stated by the manufacturer of that device that that is what they intended) -so you cannot modify devices unless those modifications were intended and tested by the original manufacturer.
Slide 16 - International harmonisation
I would like to talk now about some international harmonisation efforts in the personalised medical device space.
Slide 17 - International Medical Device Regulators Forum (IMDRF)
- Global harmonisation initiative established in 2011
- Current members are:
- Australia *
- Brazil *
- Canada *
- the European Union
- Japan *
- South Korea
- the United States*
* Founding members
Personalised medical devices working group
- Established 2017
- Australia is Chair
Australia is a member of the International Medical Device Regulators' Forum-in fact, we are one of the founding members. This is an initiative by medical device regulators around the world-and these are the main manufacturing countries around the world-to harmonise our regulations of medical devices so that there are equal safety and performance standards around the world, and also, so that industry is subject to the same requirements to make it easier to supply their devices globally. Now, in 2017, the IMDRF agreed to establish a personalised medical device working group, and Australia is chairing this working group.
Slide 18 - IMDRF documents from the PMD working group
Already this working group has published a document with definitions for personalised medical devices-this came out in November 2018, I know it says October on the cover but it wasn't actually published until November-this document includes the same definitions that we are proposing to adopt here in Australia, so we have already gone out for a global consultation on these definitions, and, we hope to make this more appealing to (and useful for) manufacturers and other stakeholders, as they are globally harmonised. The working group also has a proposed document that is expected to be published soon, within the next month, for public consultation. And this is on regulatory pathways for the different categories of personalised medical devices that were defined in the first paper. Now, these documents-the definitions document, and hopefully soon, the proposed document, are available on the IMDRF website-so that is imdrf.org, and you can find these papers online.
Slide 19 - Next steps in Australia
Use of 3D-printing for patient specific applications is increasing, but does our existing regulatory framework adequately mitigate risk for patients?
- Analyse results of current consultation
- Seek government approval for regulatory changes based on consultation proposals and responses
- Implement changes following an appropriate transition period
The next steps in Australia, would be to summarise the submissions from our consultation-as I mentioned, that's closing on March the 31st-we will analyse stakeholder feedback, and based on this feedback, we will make a proposal to the government for a regulatory reform… and, if we get approval from the government-and, as you know, we are likely to face an election very soon, so, most likely we will have to wait for the new government to put this proposal forward to; and, if it becomes approved, we will implement these changes into our regulations, and we will allow a suitable transition period for compliance by all affected stakeholders, and then we will enforce these changes.
Slide 20 - Further information
Contact the TGA Medical Devices Branch
- Email: firstname.lastname@example.org
- Phone: 1800 141 144
That concludes the presentation. I hope you found it informative… and, there is further information available on our website-that consultation paper goes into an awful lot of detail and that, even when the consultation closes, it will be available on the TGA website… so, thank you.