Guidance Document – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing - Summary

Overview

This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for 3D-printed medical devices.

Who this guide is for

Medical Device manufacturers

In this guide

• 1. Introduction
• 1.1 Overview
• 1.2 Scope and application
• 1.3 Policy objectives
• 1.4 Policy statements
• 1.5 Background
• 2. Guidance for implementation
  • 2.1 Information for Class III and IV 3D printed implantable medical device licence applications
    • 2.1.1 Device description
    • 2.1.2 Design philosophy
    • 2.1.3 Licence amendments
    • 2.1.4 Marketing history/regulatory status
  • 2.2 Safety and effectiveness
    • 2.2.1 Standards
    • 2.2.2 Preclinical studies
    • 2.2.3 Shelf life
    • 2.2.4 Software verification and validation
    • 2.2.5 Biocompatibility tests
    • 2.2.6 Animal studies
    • 2.2.7 Clinical studies
    • 2.2.8 Post-printing processing, cleaning and sterilization
  • 2.3 Device labels, package labelling and documentation
  • 2.4 Additional considerations for Class IV 3D printed implantable medical devices - process validation studies
• 3. Contact Information
• 4. Appendices
  • Appendix A - Glossary
    • Terminology related to printing processes as defined in ISO/ASTM 52900:2015
  • Appendix B - Corresponding sections of Health Canada guidance or Table of Contents (TOC) folder structure
  • Appendix C - References

View complete guide

Download PDF (271 KB, 18 pages)

Part of topic(s): Guidance on legislation, medical devices and 3D printing

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