Guidance on clinical evidence requirements for medical devices has been published by Health Canada on November 2022. The guidance is for medical device manufacturers involved in Class II, Class III and Class IV to gain details information on fulfilling clinical evidence requirements required by the government. The safety and effectiveness of medical devices have been set up as one of the requirements in Medical Device Regulations. Hence, Health Canada will review this aspect before approving the license application.
Clinical Data and Evaluation
Clinical data is one of the important components that must be prepared by the manufacturers. Clinical data consists of the safety and effectiveness information of the medical devices that are generated by clinical usage.
There are a few situations that may require clinical data submission, for instance, the medical devices may be exposed as potentially high-risk safety devices, no concrete evidence that supports the safety and effectiveness of the information provided and the medical devices developed are new for the industry.
Clinical data can be generated through the methods below:
Clinical investigations
Post-market clinical experience
Usability studies and simulation
Literature reviews
Real-world data and real-world evidence
While for the clinical evaluation phase, a manufacturer must aware that the medical devices are supposedly effective in any situation required, any possible risks were minimized compared to the effectiveness benefits and safety and effectiveness claims against the devices must be supported by the clinical evidence. For any medical devices classified under Class III and Class IV, the manufacturers may provide Clinical Evaluation Report (CER) as the report should include all the relevant critically analyzed data.
Clinical Evidence Submission
First and foremost, not all medical devices must submit clinical evidence for the license application. Among the medical devices that may be required to submit clinical evidence are new medical device technologies, modification design to the established devices, new safety and effectiveness proposed for the devices and non-supported pre-clinical testing devices.
If manufacturers are aware that any devices fall on the characteristics listed in the regulation, specifically for Class II medical devices, the manufacturer must provide a legal statement on the evidence of the safety and effectiveness of the medical devices. While for Class III, the manufacturers must submit the studies used as references and conclusions made out from the study. For Class IV medical devices, the manufacturers must submit the clinical data that ensure the device’s safety and effectiveness.
Once the medical devices meet the requirements and the risks are in minimum quantity, Health Canada may approve the license application.
License Application Amendment
The manufacturers should be responsible to declare any alteration made to the medical devices and provide clear information on how the changes may impact the indication of use from the previous function. Listed below are the characteristics that should be prioritized in determining the amendment pattern:
Materials and design
Software
Purposes or indication of use
Targeted population, users or users profile
Probability the existence of new hazards or hazardous situation
Post-Market Obligations
Health Canada is authorized to request additional clinical evidence submission if there is any issue regarding the safety or effectiveness while the devices in the market. Besides, this additional request also may prevent from any incident happening.
Health Canada will impose the terms and conditions set up previously if there is clinical performance uncertainty for the devices or the technologies. The other factor that may trigger is the ongoing or longer-term clinical follow-up for the medical devices during the license application. If this happens, the manufacturer should submit new clinical data or evidence collection if the manufacturers plan to collect long-term safety and effectiveness data and continuously follow up the clinical investigations.
Source: Health Canada
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