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International Group Sets Standards For Custom Devices

 
• By Elizabeth Orr

The IMDRF has issued new guidance on the regulation of custom devices, which incorporates recommendations reflecting new advances in 3D printing and other personalized manufacture.

3d printing in modern medical technology. Bioprinting, prosthetics.

New final guidance on the regulation of personalized devices from the International Medical Device Regulators Forum (IMDRF) reflects recent technological advances that allow custom devices to be produced at a mass scale.

The 22-page document, which is dated 28 March but posted online last week, recommends a harmonized approach to ensure custom devices are regulated consistently across IMDRF member nations. This...

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