Key steps to Post-Market Surveillance (PMS)
Medical device businesses need to stay on top of their Post-Market Surveillance activities at all times. There are some specific areas to focus on to help ensure that PMS is up to date and thorough, in this blog IMed Consultancy shares some must-monitor areas for compliant on-going PMS.
What is Post-Market Surveillance or PMS?
According to the EU MDR: “Post-market surveillance” means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions” (EU MDR Art.2, 60). The scope and effort required by such a broad range of activities is vast, but regulatory experts will be able to offer some key areas for this rigorous monitoring activity to focus on.
Key activities for compliant Post-Market Surveillance
Extensive regulatory experience has helped the team at IMed whittle down overall ongoing PMS activities into five major areas. Classifying areas for attention can help medical device manufacturers better grasp the scope of the task and its ongoing, iterative nature, as new events and information regarding their or competitor devices, continues to emerge in the real world.
1. Engaging with users of medical devices
Engaging with users and, where relevant, with patients regularly will help manufacturers assess any potential issues with their product that can only be identified through use.
Manufacturers also need to investigate any off-label use to ensure they are in no way complicit with it, even if it has become standard practice.
2. Surveillance of published literature on medical devices
Published literature involving your product and similar products provides valuable clinical evidence that can highlight risks or provide stronger proof of a product’s clinical benefit.
Relevant trade publications that cover the market of application of the device as well as broader nursing, medical or healthcare titles are also a good source of intelligence.
3. Don’t forget to monitor social media!
Patients and users have been known to share experiences over social media, providing further clinical evidence. At the same time monitoring social media interactions helps ensure that marketing and communications departments are aligned with company compliance policy and not seeming to endorse off-label use of devices.
4. Monitor competitor device performance
Competitor device performance is a good indicator of ‘clinical benefit’ and ‘state of the art’ (SOTA), both of which are important new elements of the regulations.
Should complaints or potential issues be discovered with a device that is similar, or performing the same function as the manufacturer’s device, this allows the manufacturer to assess and proactively rectify any common issue before it landslides and presents a risk to patient safety on their devices.
5. Regular risk data assessments
Reassessing the risk data for your device is not a one-off activity and should be carried out cyclically after the launch of the product. The documentation needs to be regularly updated with new statistics and data from post market surveillance, including real world data on complaints and product issues encountered.
Find out how experienced regulatory and compliance consultants can help support you in identifying these and other areas for thorough and up-to-date cyclical Post-Market Surveillance in our latest whitepaper on PMS <link>
Alternatively reach out to us directly for tailored, specialist support that takes the pressure off your in-house teams and write to hello@imedconsultancy.com