Regulatory guidance for 3D-printed medical devices

3D printing or additive manufacturing technology has revolutionized the medical device industry during the last few years. This technology enables the opportunity for patient-specific healthcare solutions. The current product range covers a broad spectrum of medical applications, such as surgical instruments, prosthetics or implants. Technology is also being developed for the 3D printing of skin, bone, tissue, pharmaceuticals, biologics and even human organs, but these applications have a long way to go to reach maturity. Various market analyses have been published recently. They speak of a current global market value for 3D-printed medical devices of around USD 2 billion and forecast growth at a compound annual growth rate (CAGR) of around 15-25% over the next five to ten years.

The term 3D printing or additive manufacturing covers a variety of processes and technologies that offer a full range of capabilities for the production of components and devices in different materials: polymers, ceramics and metals. Essentially, what all of the processes and technologies have in common is the manner in which production is carried out: layer by layer in an additive process which is in contrast to traditional methods of production involving subtractive methods or molding processes. As this type of manufacturing does not rely on molds or multiple pieces of specialized equipment, designs can rapidly be modified. 3D printing can also be used for creating patient-matched products based on the patient’s anatomy manufactured at the site of patient care or point-of-care manufacturing.

From a regulatory perspective, the 3D printing technology is accompanied by many questions and challenges for regulators and manufacturers deriving from the existing regulatory framework. The existing framework is not always specific enough to answer these questions and help with these challenges. Amongst others, more specific guidance is needed for the following aspects:

  • Medical device definition, including “custom-made” and “patient-matched”
  • Manufacturing, especially validation
  • Biological safety evaluation
  • Clinical evaluation
  • Risk management
  • Quality Management System

 Consider, for example, 3D-printed products produced at the point of care. When 3D printing is used to manufacture a medical device at the point of care, who is responsible for oversight, the regulatory authorities? It is not yet apparent how the regulatory authorities will adapt regulatory requirements to ensure that these 3D-printed products are safe and effective for their intended use. Medical device regulatory authorities do not directly regulate the practice of medicine, which is overseen primarily by medical boards or councils, are they then responsible for the supervision?

FDA’s Center for Devices and Radiological Health is developing a risk-based framework that includes five potential scenarios in which 3D printing can be used for point-of-care manufacturing of medical devices.

Table 1. Conceptual framework for 3D printing at the point of care

Some medical professional organizations are releasing guidelines for utilizing 3D printing at the point of care, which include recommendations on how to consistently and safely produce 3D-printed anatomical models generated from medical imaging, as well as criteria for the clinical appropriateness of using 3D-printed anatomical models for diagnostic use.

Gradually, more regulatory guidance is also being published. We would like to draw the attention to the following, knowing that this does not represent an exhaustive list. These guidance documents address individual regulatory aspects related to the 3D printing technology. Some of these have arisen together with the SARS-CoV-2 pandemic and the high demand for related medical devices. In addition, some ISO and ASTM standards provide supportive information for several technical aspects of the 3D printing technology.

  • IMDRF (2018): „IMDRF/PMD WG/N49: Definitions for Personalized Medical Devices“.[1]
  • IMDRF (2020): “IMDRF/PMD WG/N58: Personalized Medical Devices - Regulatory Pathways“.[2]
  • MDCG (2021): “MDCG 2021-3: Questions and Answers on Custom-Made Devices”.[3]
  • MDCG (2020): “Q&As: Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19“.[4]
  • MHRA (2020): „Guidance: 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic“.[5]
  • US FDA (2021): “3D Printing Medical Devices at the Point of Care: Discussion Paper“.[6]
  • US FDA (2017): “Guidance Document: Technical Considerations for Additive Manufactured Medical Devices”.[7]
  • US FDA (2021): “Q&As: 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic“.[8]
  • Health Canada (2019): “Guidance Document - Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing”.[9]
  • TGA (2021): “Personalised medical devices (including 3D-printed devices)“.[10]
  • HSA (2021): “Regulatory Guideline For 3D-Printed Medical Devices”.[11]
  • BSI white paper (2019): “The impact and potential for 3D printing and bioprinting in the medical devices industry“.[12]
  • TÜV Süd white paper (2021): “Validating additive manufacturing processes to meet medical regulations”.[13]
  • Carl AK and Hochmann D (2021): “Regulatory framework for 3D printed custom-made devices in Europe”.[14]
  • Adamo et al. (2018): “Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products”.[15]
  • Beitler BG, Abraham PF, Glennon AR et al (2022): “Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care.“ 3D Print Med 8,7 (2022).[16]

Further guidance is awaited and the existing regulations need to evolve with the increasing relevance of the 3D printing technology in healthcare.[17] In this context, further global harmonization would be highly desirable.

Since the use of 3D printing technologies for customizing medical devices was first mooted more than a decade ago, Qserve have consulted on the design and development of such devices, verification and validation of the product and manufacturing technology, including large scale projects funded by the European Union.

The medical device sector was one of the early adopters of 3D printing, but it is also a sector with huge potential for growth, due to the customization capabilities of the technologies and advances in 3D-printable materials. Qserve is qualified and happy to support its clients in solving the regulatory challenges related to the 3D printing technology.

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Post date: March 24, 2022
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