Regulatory frameworks of medical devices have been under scrutiny in several major export markets including the EU and Canada. In Europe, legislators have been laying down more stringent regulatory requirements with aim of improving the safety and performance of medical devices on the market. In comparison to the current legislative set-up, the new EU medical device regulation has a more risk-based approach.
Similar trends are observed in Canada whose government has recently introduced a new action plan on medical devices. Having almost identical goals in mind, i.e. to make the medical device market safer and more effective, Canada also adopts a risk-based approach to their medical device legislation. The main principle of this approach is that the level of requirements before approval depends on the level of risk the device imposes on its user.
To further enhance the safety and effectiveness of medical devices, the Canadian government has developed a threefold strategy which focusses on:
– Improving the principles of market access;
– Enhancing the monitoring and follow-up of medical device on the market;
– Increasing the information provided to medical device users;
The above action plan aligns the general development of the Canadian legislative framework with the new EU regulation which has significantly highlighted the importance of concepts such as pre-market scrutiny and post market surveillance.
Do you have more questions about the recent development in the medical device industry? Please do not hesitate to contact us or visit MDlawplatform. Obelis experts will gladly answer your questions.
Hannah Van Deun