Regulators crack down on medical device sector

Regulators are heightening post market surveillance requirements in order to ensure medical device safety issues are identified as early as possible. Maetrics has written a whitepaper on how to navigate these requirements

Regulatory bodies are implementing stringent requirements for more proactive post-market surveillance mechanisms, instead of relying on current reactive systems, such as complaints monitoring.

Maetrics said that in the EU specifically, it is crucial for manufacturers to review their systems, processes and procedures for post market surveillance to ensure that they are compliant not only with the increasingly demanding requirements expected in the new Medical Device Regulation, but also with those of the single countries they distribute to.

In order to help manufacturers stay compliant and understand these changes, Maetrics has published a free whitepaper.

Written by Parminder Kalle, senior manager, solutions delivery at Maetrics the whitepaper outlines current regulatory requirements globally as well as explaining how manufacturers worldwide can achieve post market surveillance compliance.

The guide looks in particular at the global climate that has led to increasing scrutiny on post-market surveillance by Global Regulatory Bodies, how manufacturers can successfully review post market surveillance systems, processes and procedures in time for the next Regulatory Body Audit or review and the varying post market surveillance requirements in different geographies.

It also covers the expectations of different regulating bodies, the challenges facing manufacturers and the role of personnel training in investigations and vigilance reporting.

Kalle said: “Post-market surveillance of medical devices has not always been at the forefront of the minds of medical device manufacturers, but due to recent high profile scandals, regulatory bodies across the globe are starting to impose more prescriptive requirements for post market surveillance and manufacturers cannot afford to shirk on compliance.

“Ensuring the early detection of device issues via post market surveillance is a key activity as it is critical to protecting patient safety.

“But manufacturers can also draw some immediate benefits from improving their post market surveillance as their devices enjoy improved reputation, there will be fewer complaints leading to lower handling and resolution costs and finally, having proactive post market surveillance investigation processes in place allows organisations to easily spot product, design and process improvements.”