TGA Discussion Paper 3D Printing Technology in the Medical Device Field Australian Regulatory Considerations MTAA Response - October 2017 October 2017 Australian Regulatory Considerations Page 1 of 7
Level 12, 54 Miller St, North Sydney NSW 2060 Australia P (+612) 9900 0600 F (+612) 9900 0655 Contents 1 Introduction... 3 2 International Context... 3 3 New definitions... 4 4 Responses to questions raised in the TGA Discussion Paper... 5 4.1 Statement of compliance with Essential Principles... 5 4.2 Regulatory status of 3D printers and anatomical models... 5 4.3 Regulatory status of 3D printed medical devices... 5 4.4 Regulatory status of entities engaged in 3D printing of medical devices... 6 4.5 Standards applicable to 3D printed medical devices... 6 4.6 Regulatory requirements to adequately protect consumers... 6 4.7 Other questions... 7 Copyright 2017 Medical Technology Association of Australia Limited (MTAA) To the extent permitted by law, all rights are reserved and no part of this publication covered by copyright may be reproduced or copied in any form or by any means except with the written permission of MTAA Limited. October 2017 Australian Regulatory Considerations Page 2 of 7
1 Introduction The Australian Medical Technology industry has successfully been utilising 3D printing for several decades, and recent technological advancements have improved the availability and the application of this technology. Currently 3D printers are generally considered to be manufacturing equipment that do not fall under the definition of a medical device and MTAA believes that 3D printers should not be regulated as a medical device unless they are intended by the Manufacturer or sponsor to be a medical device as defined by the Act. Custom made medical devices have been heavily influenced by this technology and we recommend regulatory reform to maintain Australia s high safety and efficacy standard of medical devices in the market as the use of this technology expands. 2 International Context On 17 th July 2017, the TGA circulated the discussion paper 3D Printing Technology in the Medical Device Field Australian Regulatory Considerations. The discussion paper was the subject of a subsequent workshop held on 10 th August 2017, where stakeholders from industry, healthcare professionals, consumer advocacy groups, science and academia exchanged views and expressed concerns. The recently adopted European Medical Device Regulation (MDR) 2017/745 of 5 April 2017 has introduced significant changes compared to the old Medical Devices Directive (MDD) 93/42/EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. Among the changes is a revised definition of custom-made devices 1 : custom-made device means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices; Although the EU MDR does not specify what constitutes mass-produced, the US FDA sets the limit for custom-made devices at no more than 5 units per year of a particular device type. In addition, the FDA has introduced further restrictions to the use of custom-made devices, which can only be used for treating a sufficiently rare condition, such that conducting clinical investigations on such a device would be impractical. 2 1 http://eur-lex.europa.eu/legal-content/eng/txt/pdf/?uri=celex:32017r0745&from=en 2 https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm415799.pdf October 2017 Australian Regulatory Considerations Page 3 of 7
The Australian regulations define a custom-made device a 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. The Australian definition for custom-made devices should be retained in its current form, because it specifically covers custom-made tools and instruments intended to be used by healthcare professionals. MTAA appreciates the opportunity to be involved in the consultation process for updating the regulatory framework to accommodate the use of 3D printing technology. MTAA identifies the need for dynamic legislation that supports the use of advancements in technology either in the medical device or the manufacturing process. MTAA supports similar legislative changes to custom made medical devices implemented in Europe and the USA to support the safe and effective use of 3D printing/ additive manufacturing. In the next sections, we provide more details in response to the TGA Discussion Paper. 3 New definitions The TGA Discussion Paper proposes the introduction of following definitions: customised medical devices a mass produced medical device that is supplied by a manufacturer with a specified intended purpose and that must be adapted or assembled, in accordance with the manufacturer s instructions, to suit an individual patient prior to use mass produced medical devices - medical devices that are produced in production runs or batches that consist of identical products. There may be different batches or runs of different sizes, but within a batch the items are identical. patient matched or patient specific devices based on a standard device template model that is matched to a patient s anatomy. Patient-matching can be accomplished by techniques such as scaling of the device using one or more anatomic references, or by using the full anatomic features from patient imaging. (from the FDA Additive Manufactured Devices Guidance 3 ) MTAA supports the introduction of these definitions with the highlighted change to assist in clarifying terminology used in relation to 3D printed medical devices. 3 https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm499809.pdf October 2017 Australian Regulatory Considerations Page 4 of 7
4 Responses to questions raised in the TGA Discussion Paper 4.1 Statement of compliance with Essential Principles The TGA Discussion Paper asks whether Australian health consumers would benefit from adopting the European approach of providing a written statement in relation to compliance and justification of non-compliance of custom-made devices with the applicable Essential Principles (page 15 of the TGA Discussion Paper). We believe that, unless the reader is familiar with the Essential Principles, it is of little value to provide such a statement to lay persons. However, we support the requirement for the manufacturer to prepare and keep on file such a statement and provide it upon request to the TGA, the treating healthcare professional or the patient. 4.2 Regulatory status of 3D printers and anatomical models Currently 3D printers are generally considered to be manufacturing equipment that do not fall under the definition of medical devices, although they are used to make products that meet the definitions of a medical device (page 19 of the TGA Discussion Paper). We believe that 3D printers should not be regulated as medical devices unless they are intended by the Manufacturer or sponsor to be a medical device as defined by the Act. Anatomical models should be regulated as custom-made medical devices only if they are printed from imaging scans of a particular patient for the purpose to be used as a diagnosis or investigation of the anatomy of the patient. 4.3 Regulatory status of 3D printed medical devices In our opinion, a 3D printed medical devices should be regulated as one of the following: Custom-made devices if they fall under the existing definition of custom-made device and aligned with the latest definition of custom-made device in the EU MDR, i.e. they are not mass produced as per the new proposed definition; Custom-made devices should continue to be exempt from inclusion in the ARTG. It is understood though that ARTG inclusion will remain a condition for obtaining reimbursement using the standard health technology assessment (HTA) processes. Patient matched or patient specific devices if they are mass produced based on a standard device template model that is matched to a patient s anatomy, using one or more anatomic references, or by using the full anatomic features from patient imaging, i.e. as per the new proposed definition; Patient matched/ specific devices should be required to be included in the ARTG and should qualify for reimbursement, like any other medical devices. 3D printed implants that are patient matched/ specific devices should be considered to be of a kind that is not exempt, and be subjected to the rigorous premarket scrutiny applicable to implantable devices. Verification/ validation should be done on samples that October 2017 Australian Regulatory Considerations Page 5 of 7
bracketed the worst-case size configurations, to demonstrate compliance with applicable Essential Principles. We agree that the 3D printing process is more than assembly or adaptation for a particular patient by an entity other than the original manufacturer, which applies to customised devices. Hence 3D printed devices cannot be considered customised devices, as per the new proposed definition. 4.4 Regulatory status of entities engaged in 3D printing of medical devices Custom-made devices should continue to be exempt from entry in the ARTG and entities making custom-made devices should continue to be exempt from pre-market regulatory requirements applicable to manufacturers. However, entities such as hospital laboratories engaging in making patient matched/ specific devices on a commercial scale (i.e. mass produced) should be regulated as manufacturers. Manufacturer responsibilities include operating according to a quality management system as per ISO 13485; applying conformity assessment procedures suitable for the risk classification of the medical device; and post-market obligations such as reporting of malfunctions and adverse events. The regulatory treatment of 3D manufacturing should be the same as that of conventional subtractive manufacturing when it is used as an alternative to conventional subtractive manufacturing for standard off-the-shelf devices. 4.5 Standards applicable to 3D printed medical devices MTAA agrees that state-of-the-art standards that are applicable to medical devices in general should be applicable to 3D printed medical devices as well to demonstrate compliance with the Essential Principles of safety and performance. 4.6 Regulatory requirements to adequately protect consumers 3D printing technology has democratised medical device manufacturing due to its relative affordability. This has led to an increase in the number of entities engaging in manufacturing of medical devices, including of high-risk implantable devices. The number of high-risk 3D printed implants is on the rise and this represents an increase in risk to patient population. It is therefore important to distinguish between custom-made devices (that, by definition, are only made in very low numbers) and patient specific devices (that, by definition, are mass produced). The patient specific medical devices need to be regulated like any other medical devices, and entities engaging in 3D printing of such devices must be regulated as medical device manufacturers. October 2017 Australian Regulatory Considerations Page 6 of 7
4.7 Other questions Q1: Is the current custom-made regulatory pathway appropriate for patient specific 3D printed implantable medical devices and does this represent an appropriate level of risk mitigation for patient? A1: In our opinion, the current regulatory framework for custom-made devices does not represent an appropriate level of risk mitigation for patient specific 3D printed implantable medical devices manufactured on a commercial scale. Entities engaging in manufacturing patient specific 3D printed implantable medical devices should be regulated as manufacturers and such devices should be regulated as any other implantable medical devices. Q2: If the answer to Question 1 is no, then a fairly straightforward change could be to amend the definition of custom-made device in the Regulation. Is this a reasonable approach and is it enough? A2: The definition of custom-made devices should remain as is, but additional definitions for mass produced and patient specific medical devices should be included in the regulations, to differentiate the regulatory treatment of mass produced patient specific 3D printed devices from that of custom-made devices. Q3: What regulatory changes should be applied to ensure it is clear that the exclusion from being considered the manufacturer, i.e. in the case of customised does not apply to 3D printed devices? Should there be different arrangements for lower risk devices? A3: The definition of customised medical devices should be included in regulations to distinguish between entities, other than the original manufacturer, engaging in customising devices for a particular patient and entities engaging in the mass production of 3D printing patient specific devices. Different arrangement should apply to lower risk devices such as dental devices in Class I, IIa and IIb risk classification. Q4: What about 3D printed anatomical models what risk classification should be applied to them? A4: 3D printed anatomical models should be classified as Class IIa only when they are mass produced patient specific devices. October 2017 Australian Regulatory Considerations Page 7 of 7