Guidance Document - Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing (French, HTML)

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Publisher-reported update

2023-12-29

This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for 3D printed medical devices. As with all Class III and IV medical devices, devices produced by additive manufacturing or 3D printing, are subject to the Medical Devices Regulations (Regulations) and require a review of submitted evidence of safety and effectiveness before a licence can be issued.

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