3D printing technology in the medical field allows for the creation of patient-specific devices, leading to innovations in orthopedics, dental, and cranial implants. The FDA is exploring regulatory measures for these devices through its Additive Manufacturing of Medical Products lab, focusing on safety and performance metrics. As the technology evolves, regulations are expected to adapt, particularly concerning patient-specific devices which currently only require a prescription and are not mandated to have a CE mark.

1. 3D Printed Medical Devices
By: Madison Wheeler
Recently, 3D printing technology has seen a boom in popularity among many different
industries, including medical devices. 3D printing medical devices allow manufacturers to easily
create devices that function with a patient’s anatomy (also known as patient-specific devices).
For this reason, 3D printed medical devices are especially popular for orthopedic, dental, and
cranial implants and external prosthetics.1 Like most emerging technologies for medical devices,
the FDA must get ahead of the trend in order to determine how they will regulate the devices.
The FDA refers to 3D printing of medical devices as “additive manufacturing” due to how unlike
conventional manufacturing where a device is cut and shaped, 3D printing simply places the
material where it is needed. In order to study how exactly devices created from additive
manufacturing function and behave versus conventionally manufactured devices, the FDA has
created the Additive Manufacturing of Medical Products (AMMP) Lab. This lab explores the
safety and performance of 3D printed medical devices by focusing on the following:
1. Methods to assess the cleaning of 3D printed devices. Since these devices are usually
complex, how to clean them and how hard it is to assess cleanliness needs to be
understood.
2. 3D printing to evaluate optical imaging diagnostics. Since additive manufacturing can
allow medical devices to have extremely biologically accurate shapes, the FDA must
assess their current radiographic imaging technologies against what is possible with these
new devices.
3. Determining metrics for measuring patient-specific instrumentation. How do you
determine pass/fail criteria for testing on a device when it is specific to one person? How
do you create metrics for patient-specific devices when each device will be different?2
For now, 3D printed devices are regulated and classified in the same way conventional devices
are. As the technology develops and regulatory agencies understand how it functions better, you
can expect to see regulations around it change. For example, as the transition to the new EU
MDR and IVDR regulations is underway, additive manufacturers can expect their devices to be
potentially re-classified. Additionally, under the current regulations, patient-specific devices are
1 FDA (October 2019) 3D Printingof Medical Devices retrieved on 1/7/2020 from: https://www.fda.gov/medical-
devices/products-and-medical-procedures/3d-printing-medical-devices
2 LT James Coburn, MSc, FDA (September 2018) Additive Manufacturingof Medical Products retrieved on 1/7/2020
from: https://www.fda.gov/medical-devices/cdrh-research-programs/additive-manufacturing-medical-products

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not required to have a CE mark only a prescription from a doctor; however, that regulation is
currently being reviewed.3
3D printing medical devices brings a whole new level of personalization to medicine. As the
technology develops, so are the conversations regulating agencies are having around the safety
and effectiveness of them. EMMA International can help you navigate the quality and regulatory
requirements for your medical device, even a 3D printed one. Contact us at 248-987-4497 or
email info@emmainternational.com to see how we can help!
3 Dalgarno,BSI (November 2019) 3D printingand medical deviceregulation retrieved on 1/7/2020 from:
https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/3d-printing-and-medical-device-regulation/