Parminder Kalle advises on how to navigate post market surveillance for medical devices to ensure regulatory compliance and to protect patients and staff from potential risks.
Post market surveillance is the practice carried out by medical device manufacturers to monitor the safety of a product once it has been released onto the market. Unfortunately this is an area of regulatory compliance that manufacturers take a more relaxed approach to. However, forthcoming changes means there is going to be a big shake-up with how manufacturers should handle their post market surveillance, as they will need to start to look at implementing proactive mechanisms when it comes to ensuring they are keeping compliant and keeping patients and device users safe.
Due to recent scandals in the medical device industry – specifically, PIP breast implants and metal-on-metal hip implant issues – regulatory bodies have come under increased pressure from competent authorities to enforce a renewed focus on how device safety should be monitored. These particular events have highlighted to the regulatory authorities that post market surveillance is an area which was getting neglected and consequently they are now implementing stricter rules which will see manufacturers taking a more proactive approach to their post market surveillance rather than relying solely on reactive systems like complaints monitoring.
Not only this, but in Europe the new Medical Device Regulation (MDR) sets out to ensure that device safety issues are identified as early as possible in the process by enforcing more stringent requirements for post market surveillance.
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