GLOBAL 3D PRINTED MEDICAL DEVICES MARKET ANALYSIS

Regional Analysis

North America region held dominant position in the global 3D printed medical devices market in 2019, accounting for 46.0% share in terms of volume, followed by Europe.

Regulations

North America

• Under U.S. FDA,
• Center for Devices and Radiological Health (CDRH) regulates 3D printed medical devices
• Center for Biologics Evaluation and Research regulates 3D printing in biologic applications
• Center for Drug Evaluation and Research regulates 3D printing in drug development applications
• In May 2016, the U.S. FDA noted Design and Manufacturing Considerations and Device Testing Considerations as two broad areas for addressing quality-related issues, verification and validation of pre-marketing approvals for 3D devices

• The U.S. FDA has emphasized the importance of assessment of material control, 3D printer, and post-printing processes for successfully evaluating device performance
• According to the U.S. FDA, mechanical testing for 3D printed devices should take into account a device's build orientation relative to the 3D printer
• The U.S. FDA approves majority of devices in 3D printing technology as Class II