3D Printed Implantable Devices: Health Canada Offers Guidance
Posted 01 May 2019 | By
Health Canada on Tuesday unveiled new guidance discussing what evidence is required to support pre-market Class III and Class IV license applications for implantable medical devices manufactured via 3D printing.
While making distinctions between patient-matched 3D printed devices and devices manufactured to prespecified sizes, the guidance explains everything from how the devices should be designed to what preclinical and clinical studies should be run, in addition to shelf life considerations.
“As part of the evidence to demonstrate the safety and effectiveness of a Class III or IV 3D printed device, manufacturers should submit the additional information outlined in this guidance document with their application,” Health Canada says.
As far as such additional information, the guidance explains how the device description should state whether the entire device or only a component of the device is 3D printed, whether the device is patient matched, or if characterization of a starting material is required.
“The description of the 3D printing method (e.g., laser sintering, direct metal laser sintering and powder bed fusion) should be provided in addition to an overview of the printing process including post-printing processing steps. Quality control procedures should also by identified in the overview of the manufacturing process,” the guidance says.
As for clinical data, Health Canada says 3D printed device-specific data may be required, although a literature review from peer-reviewed scientific literature may suffice if the device design and intended use are well-established.
Additional shelf life considerations related to 3D printed devices may include:
- “effects on long term material stability (with respect to inter-layer bonding and homogeneity across build layers)
- possible time-dependent changes to patient anatomy for patient-matched devices, and
- raw material shelf life (where applicable).”
Other sections of the guidance discuss biocompatibility testing, post-printing processing, cleaning and sterilization, and software verification and validation.