Discussion paper on proposed new regulatory changes on 3D technology: a surgical perspective

Mukherjee, Payal; Clark, Jonathan; Wallace, Gordon G.; Cheng, Kai; Solomon, Michael J.; Richardson, A. J.; Maddern, Guy J.

doi:10.1111/ans.14946

Cited by 5 publications

(3 citation statements)

References 23 publications

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“…The proposed legislation in Australia [ 54 ] shares many similarities, where models are considered medical devices, and individual clinicians producing them would have to assume the full responsibility of a manufacturer. The Australian Therapeutic Goods Administration also publishes proactive guidelines on medical device classification under the coming new legislation, including the distinction between patient-matched and custom-made medical devices [ 55 ].…”

Section: Discussionmentioning

confidence: 99%

Core Legal Challenges for Medical 3D Printing in the EU

Pettersson,

Ballardini,

Mimler

et al. 2024

Healthcare

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3D printing has been adopted into routine use for certain medical applications, but more widespread usage has been hindered by, among other things, unclear legislation. We performed an analysis, using legal doctrinal study and legal informatics, of relevant EU legislation and case law in four issues relevant to medical 3D printing (excluding bioprinting or pharmacoprinting): pre-market approval, post-market liability, intellectual property rights, and data protection. Several gaps and uncertainties in the current legislation and interpretations were identified. In particular, we regard the current EU regulatory framework to be quite limiting and inflexible, exemplifying a cautionary approach common in EU law. Though the need to establish high safety standards in order to protect patients as a disadvantaged population is understood, both legal uncertainties and overregulation are seen as harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes.

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Section: Discussionmentioning

confidence: 99%

Core Legal Challenges for Medical 3D Printing in the EU

Pettersson,

Ballardini,

Mimler

et al. 2024

Healthcare

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“…However, whether CAD files are afforded legal protections is still undetermined. Moving from printed models of patient anatomy into tools, external aids and implants, legal issues over IP rights become increasingly relevant, and even more so if hospitals start manufacturing their own medical devices based on existing designs, as has been predicted (Laakmann, 2016;Jackson, 2017;Mukherjee et al, 2019).…”

Section: Intellectual Property Rights (Ipr): Cad Files Again At the C...mentioning

confidence: 99%

Legal issues and underexplored data protection in medical 3D printing: A scoping review

Pettersson

Ballardini²,

Mimler³

et al. 2023

Front. Bioeng. Biotechnol.

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Introduction: 3D printing has quickly found many applications in medicine. However, as with any new technology the regulatory landscape is struggling to stay abreast. Unclear legislation or lack of legislation has been suggested as being one hindrance for wide-scale adoption.Methods: A scoping review was performed in PubMed, Web of Science, SCOPUS and Westlaw International to identify articles dealing with legal issues in medical 3D printing.Results: Thirty-four articles fulfilling inclusion criteria were identified in medical/technical databases and fifteen in the legal database. The majority of articles dealt with the USA, while the EU was also prominently represented. Some common unresolved legal issues were identified, among them terminological confusion between custom-made and patient-matched devices, lack of specific legislation for patient-matched products, and the undefined legal role of CAD files both from a liability and from an intellectual property standpoint. Data protection was mentioned only in two papers and seems an underexplored topic.Conclusion: In this scoping review, several relevant articles and several common unresolved legal issues were identified including a need for terminological uniformity in medical 3D printing. The results of this work are planned to inform our own deeper legal analysis of these issues in the future.

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“…In recent years, rapid advancement and uptake of 3D‐printing in surgery 1,2 has necessitated new regulatory guidelines from the Therapeutic Goods Administration (TGA) in Australia to ensure compliance of all Personalised Medical Devices (PMDs) with the Essential Principles 3 for design and manufacturing requirements of medical devices. Six of the Essential Principles apply to all medical devices, covering safe use and design of the device, suitability for intended purpose, benefits outweighing side effects, and effects of transport and storage, and a further nine Essential Principles apply to medical devices on a case‐by‐case basis 4 .…”

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confidence: 99%