Implanted devices manufactured by 3-D printing are gaining more and more popularity nowadays. Canadian legislators are working to keep the existing regulations up to date and harmonized with the modern foreign standards. The abovementioned medical devices are Class III and Class IV medical devices. This means that to be able to sell the new device, manufacturers need to file an application, provide clinical trial data, evidence of effectiveness and safety confirmation to obtain approval of the regulatory authority. The Guidance recently released is intended to clarify the regulatory requirements to the initial device application and the whole approval process.
The new Guidance includes the list of information that should be present in the application. First of all, an application should include a detailed description of the device with appropriate images of the device and its separate parts. There are special requirements applied to 3-D printed devices. For example, the application should include information on the components of the material used to create the device (meaning the details on chemical composition of raw materials). It is also necessary to provide information on the exact printing method used to create the particular device and the reasoning of choosing such printing for manufacturing the devices. For example, 3-D printing could be the best solution due to the complexity of the shapes of the device or high personalization requirements.
Some devices could be created according to the data of each patient. This means that there are no predefined standard sizes and each device should be created for each individual patient. In such case it would be necessary to include to the application the information on calculation methods used to adjust the measures of the device to the needs of patients.
In some cases, the manufacturer could be obligated to file an amendment to the initial application. Such amendment would be necessary in case of changing the composition or manufacturing method.
A manufacturer would also have to sign the Declaration of Conformity stating that the device falls within the applicable regulatory standards. At the same time, the manufacturer could use any international standards to confirm the safety and effectiveness of the device.
An application should also include information regarding the pre-clinical trials conducted to test the final version of the medical device before bringing it to market. According to the Guidance, the pre-clinical trials should include the following tests:
- Tensile and flexural strength
- Dynamic fatigue strength
- Compressing, bending and shear strength
All of the criteria would be checked by the domestic regulating authority during the application reviewal process. The main goal of this is to confirm that the device would perform normally during the exploitation period..
The Guidance also include information on labeling requirements applied to the above-mentioned medical devices.
The Review Process
As usual, the review process conducted by the regulatory authority includes the following necessary elements:
- Physical testing
- Mechanical testing
- Biocompatibility testings (to find out whether the device would cause “conflict” with the human being)
- Software validation
- Clinical effectiveness evidence
Manufacturers have to submit information on the effectiveness and the regulating authority is entitled to request additional information during the process of reviewing the application.
3-D Printing Market
According to the analyst reports, 3-D printed medical devices is one of the fastest growing markets among all spheres of medical devices. It
A Guidance is a special document aimed to clarify the regulatory framework and explain the main issues to all whom it may concern. It has no legal power, but could help manufactufacturers understand the existing or upcoming requirements. The RegDesk™ platform makes all reasonable efforts to provide companies operating with medical devices with the most important information related to regulatory issues, both existing and upcoming. Contact a representative today to find out more about the state-of-the-art platform and how it could benefit your team!