EMERGO BY UL SUMMARY OF KEY POINTS:

• Health Canada issues guidance for 3D-printed medical device manufacturers for what to include in MDL applications;
• Guidance covers data to include for design and manufacturing, material controls, labeling and related issues;
• Guidance applies to Class III and IV 3D-printed implantable devices.

Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices regarding what to include in their Medical Device License (MDL) applications and commercialize in the country.

The guidance covers design and manufacturing processes, material controls, testing and labeling recommendations for companies with Class III and Class IV implantable devices produced via additive manufacturing. Health Canada explicitly excludes standalone software, custom-made medical devices and bio-printed products from the scope of the guidance.

Health Canada notes that its recommendations for 3D-printed medical device regulatory requirements track closely to those issued by the International Medical Device Regulators Forum (IMDRF) and US FDA.

MDL application components 3D-printed device manufacturers should provide

Beyond general requirements Health Canada has established for all implantable Class III and IV MDL submissions, the regulator has now also specified additional submission data expected from 3D-printed device manufacturers.

Below, we discuss Health Canada MDL application data specifically required for 3D-printed devices:

Device description

The device description of the MDL application should cover not only the finished device but also starting material information, including references to any pertinent material standards; starting material chemical composition; and identification of any additives or processing agents added to the starting material.

MDL submissions for devices that have been patient-matched or custom-made instead of produced according to predetermined specifications should include the following information in their device description sections:

• Overview of 3D printing process
• Key device design parameters
• Design parameters altered to meet patient-matched specifications
• Critical features

Health Canada states that evaluation of these and related parameters will be used to determine suitability of a 3D-printed device’s starting material.

Additional information required under the “device description” category include design philosophy (i.e., why the MDL applicant chose additive rather than more conventional manufacturing methods for the device); any data regarding proposed device changes or modifications if the manufacturer is submitting a license amendment application; and marketing history as well as regulatory status either for the device itself or for a relevant and comparable device already approved by Health Canada.

Safety and effectiveness

Safety and effectiveness claims in MDL submissions for 3D-printed devices should be supported by materials including:

• Standards: All standards applied to device design and manufacturing should be listed in MDL applications; declarations of conformity should also be included for standards recognized by Health Canada.
• Preclinical studies: Health Canada proscribed preclinical performance testing for final, finished 3D-printed devices; MDL applicants should include summaries of these tests in their submissions to Health Canada.
• Shelf life considerations: 3D-printed device manufacturers should provide shelf-life-related information including effects on long-term material stability, time-dependent changes pertaining to patient-matched devices and raw material shelf life in their MDL submissions.
• Software verification and validation: MDL applications for patient-matched devices should include overviews of software-related workflows covering all phases of design and manufacturing/printing.
• Clinical studies: Health Canada requires clinical data for some 3D-printed devices utilizing novel designs, materials or intended uses; the regulator recommends MDL applicants contact its Medical Devices Bureau for guidance and recommendations for device-specific clinical data requirements.

Labeling and documentation

Proper device design and identification labeling must also take into account patient privacy and confidentiality regarding patient-matched devices, according to the guidance.

Health Canada suggests patient name, anatomical location for implantation, and/or final design iteration or version of device production method as potentially suitable labeling items.

Related Canadian medical device regulatory information from Emergo by UL:

• Health Canada Medical Device License (MDL) consulting
• Canadian medical device classification consulting
• CMDCAS, MDSAP and Health Canada ISO 13485 QMA compliance support
• Whitepaper: Overview of regulations for 3D printed medical devices