Guidance document : supporting evidence for implantable medical devices manufactured by 3D printing. : H164-274/2019E-PDF

"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. This guidance document should be read in conjunction with the Guidance Document on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)"--Introduction, page 5.

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