Regulation of Personalised, including 3D Printed, Medical Devices
Dr Elizabeth McGrath
Acting Assistant Secretary
Medical Devices Branch
Therapeutic Goods Administration
ARCS, 22 August 2018
Slide 1 - Australian Context
Personalised devices currently regulated as custom-made devices
Slide 2 - In Australia, custom-made devices
- Are exempt from Inclusion in the Australian Register of Therapeutic Goods
- Are not subject to third party oversight of manufacturing or evidence of compliance with the Essential Principles
- Are required to be notified to the TGA and have post market surveillance and reporting requirements in place
Slide 3 - 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 TGA consulted on options for regulatory requirements to address risks posed by those higher risk medical devices which are custom-made
Slide 4 - Some international approaches to regulation
US - Most 3D printed patient-specific devices subject to normal pre-market requirements
- Custom-made devices must only be for treating a "sufficiently rare condition, such that conducting clinical investigations on such a device would be impractical"
- Production of the device must be "limited to no more than five units per year"
- Manufacturer is required to submit an annual report
EU - Certification for manufacturers of high risk custom-made devices
- The new 2017 EU Medical Devices Regulation requires that manufacturers of high risk custom-made devices will now require notified body certification
Canada
- has an application process for the use of custom-made devices.
IMDRF
- is currently developing recommendations for a harmonised approach to defining medical devices manufactured for particular individual/s
Slide 5 - TGA's activities
- Stakeholder workshop August 2017
- Numerous meetings with Australian stakeholders and international regulators Sep 2017 - June 2018
- Public consultation in Nov - Dec 2017
- In May 2018, the submissions and a summary of the response were published on TGA website
- Stakeholder workshop July 2018
Slide 6 - Proposals for regulatory change
Proposal 1: New definitions for personalised devices
- customised / adaptable medical device
- a mass-produced device that must be adapted or assembled at the point of care, to suit an individual patient's anatomy
- patient-specific medical device
- manufactured based on a standard device template model, or specified design envelope that is matched to a patient's anatomy
- custom-made medical device
- intended for the sole use of a particular individual; made on request of the healthcare professional and intended to address the specific anatomy or pathological condition of the patient
Application or Number limits for custom-made devices?
Slide 7 - Responses to proposal 1:
- A range of responses regarding the proposed definitions - also need to consider international regulator views and potential for alignment
- Suggestions to include examples aligned to each definition
- Most submissions not in favour of a limitation in the number of custom-made devices to be produced by one manufacturer per year (as per the USA)
- Few submissions commented on the proposed application and approval process for custom-made devices (as per Canada).
Slide 8 - Proposal 2: Changes to the custom made device conformity assessment procedure
- The manufacturer's statement about a custom made device is provided to the patient (as per in the EU)
- TGA be allowed to enter and inspect custom made device manufacturing sites
- An Australian manufacturer or sponsor of custom made devices to provide an annual report to the TGA
- Documentation about an implantable custom made device to be maintained for at least 15 years
Slide 9 - Reponses to proposal 2 were positive throughout
- Some comments on added cost and administrative burden from annual reporting and requirement to store device-related data for a longer period
- No objections to allowing the TGA to enter and inspect custom-made medical device manufacturing sites
Slide 10 - Proposal 3: Changes to the definition of manufacturer
- To clarify when someone, who modifies a supplied device for an individual, does not meet the regulatory requirements of a manufacturer
- To address new paradigm of point-of-care manufacturing for health care facilities and practitioners - introduction of ‘medical device production system'
Only half of the submissions commented on proposal 3
- Of those, half agreed with the TGA's proposal while the other half raised issues such as need for further
- clarification on "medical device production system" Proposed exemptions for health care practitioners/hospitals not fully supported
- Uncertainty about what exactly should be considered a medical device production system and request for examples
- Comments on potential added cost and administrative burden
Slide 11 - Proposal 4: New classification for anatomical models and digital 3D files
- Up-classification of software and anatomical models intended for diagnosis or investigation of the anatomy to class IIa
- This would not apply to hospitals or healthcare practitioners that use a medical device production system to produce the anatomical models for treating their patients, and the medical device production system was included in the ARTG
General support for Proposal 4
- Some concerns about the potential additional cost and administrative burden that would arise from reclassification
- Concerns as to which anatomical models would be captured under the new provision (e.g. anatomical models used for education ?)
- Some submissions debated whether the reclassification would be enforceable
Slide 12 - Proposal 5: New arrangements for devices with human material
- Devices containing human material to not be regulated as biologicals (cell and tissue products) but as Class III devices
Responses to proposal 5 were positive
- Welcomed the plan to align with other regulators for these types of products
- One submission requested clarification on devices that are made wholly from substantially altered human material (e.g. fixation pin made from human bone)
- A suggestion to differentiate between products with different cell types
Slide 13 - The International Perspective:
IMDRF Personalized Medical Devices Working Group
Chair: Australia
NWIP Purpose:
Harmonised Definitions
Aligns with IMDRF Strategic Priorities
Slide 14 - Progress
- Established Working Group membership - all member jurisdictions represented, also two Affiliate Organization members.
- Reviewed GHTF foundation documents for references to custom-made devices.
- Conducted Working Group member survey for definitions in own country regulations or guidance that address personalized medical devices.
- Developed draft document proposing relevant definitions.
- Conducted public consultation and revised draft
- Submitted revised draft to IMDRF MC for September meeting
Slide 15 - WG Member Survey - Summary
| Jurisdiction |
Regulatory definition for custom-made |
Regulatory definition for other personalized devices |
Any guidance material related to personalized devices |
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| AHWP |
N/A |
N/A |
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| China |
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| Korea |
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| United States |
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Slide 16 - IMDRF Draft Document
Slide 17 - Proposed definitions in draft document
adaptable medical device - a medical device that meets the following requirements:
- it is mass-produced; and
- it is adapted, adjusted, assembled or shaped at the point of care, in accordance with the manufacturer's validated instructions, to suit an individual's specific anatomo-physiologic features prior to use.
Slide 18 - Proposed definitions in draft document
patient-matched medical device - a medical device that meets the following requirements:
- it is matched to a patient's anatomy within a specified design envelope using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; and
- it is typically produced in a batch through a process that is capable of being validated and reproduced; and
- it is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare professional.
Slide 19 - Proposed definitions in draft document
patient-matched medical device (continued)
Note 1: A written request from an authorized healthcare professional is not mandatory.
Note 2: The number and type of design inputs in consultation with a healthcare professional may vary depending on the medical devices to be manufactured.
Note 3: The design must remain within the validated parameters of the specified design envelope.
Slide 20 - Proposed definitions in draft document
custom-made medical device - a medical device that, at a minimum, meets the following requirements:
- it is intended for the sole use of a particular individual (which could be a patient or healthcare professional); and
- it is specifically made in accordance with a written request of an authorized healthcare professional, which gives, under their responsibility, specific design characteristics; and
- it is intended to address the specific anatomo-physiological features or pathological condition of the individual for whom it is intended.
Slide 21 - Proposed definitions in draft document
custom-made medical device (continued)
Note 1: Medical devices that are patient-specific, adaptable or mass-produced shall not be considered to be custom-made.
Note 2: A custom made device is intended for a case where an individual's specific needs cannot be met, or cannot be met at the appropriate level of performance, by an alternative device available on the market.
Slide 22 - Proposed definitions in draft document
- personalized medical device - a generic term to describe any of the types of medical devices that are intended for a particular individual, which could be either a custom-made, patient-specific, or adaptable medical device.
Slide 23 - Working Group Timeline
April/May 2018 - Public Consultation → Jun 2018 - Face to Face Mtg to Incorporate Public Comments → Jul/Aug 2018 - Teleconferences Finalise Draft → Sept 2018 - MC Consideration Final Draft & NWIP for Phase 2 → Oct 2018 -Kickoff Phase 2 Guidance for Regulatory Pathways
Slide 24 - Conclusion
- Further clarification and consultation is required
- For medium to high risk devices, both patient-matched and mass-produced devices need reasonable regulatory oversight
- current custom-made device regulation is no longer fit for purpose
- Next Steps:
- Continue IMDRF Work
- October 2018 - Conduct 2nd consultation in Australia for regulatory reform
- November/December 2018 - Analyse consultation responses, prepare policy recommendation
- December 2018 - Seek policy approval to amend regulations
Slide 25 - Thank you - Questions?
Slide 26 - END SLIDE
