Oct 11, 2018

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada to publish new guidance on MDL requirements for 3D-printed medical devices.
  • The Draft guidance will cover Class III and Class IV 3D-printed devices.
  • Publication expected in fall 2018.

Canadian medical device market regulator Health Canada plans to publish new draft guidance on Medical Device Licensing (MDL) for 3D-printed devices in the near future.

In a new notice, Health Canada states that 3D-printed devices are generally subject to the same pre- and post-market regulatory requirements as other devices; specific guidance for these devices is necessary, however, due to issues related to additive manufacturing processes.

Focus on higher-risk 3D-printed devices

Health Canada’s new guidance will focus on MDL requirements for Class III and Class IV implantable devices manufactured according to ISO 13485 quality requirements.

“In keeping with international standards, the draft guidance document will adopt definitions developed by the International Medical Device Regulators Forum (IMDRF) and elaborate on pre-market licensing requirements, including additional considerations related to the design and manufacturing processes, material controls, device testing, and labelling of 3D-printed devices,” states the regulator.

The new guidance will not cover issues such as standalone software, custom-made or patient-specific devices, or devices with biological components.

Publication timelines

Health Canada plans to issue draft guidance on MDL requirements for 3D-printed devices before the end of 2018, followed by final guidance in spring 2019.

Additional Canadian medical device regulatory resources from Emergo by UL:

  • Health Canada MDL and Medical Device Establishment License (MDEL) consulting
  • Health Canada medical device classification consulting
  • Canadian Medical Devices Regulations (CMDR) consulting
  • Whitepaper: Overview of regulations for 3D printed medical devices
  • Whitepaper: Preparing a Health Canada MDL application
  • Regulatory process chart: Health Canada MDL registration