First, let’s give a definition for Post Market Surveillance. Post Market Surveillance is the collection of observational data after, in this case, a medical device has been approved to be sold on the market. This is a phase where the medical device is observed when used amongst individuals in the general public.
In the EU, the Medical Device Regulation (MDR) requires Post Market Surveillance on all devices, but the degree varies based on risk and device type. The MDR also requires a well written post market surveillance plan on all devices.
In the US, Post Market Surveillance is mandated in most cases by the Food and Drug Administration (FDA) for certain class II or class III medical devices. A medical device development requires five phases and the fifth phase is called Post-Market Device Safety Monitoring.
Why is Post Market Surveillance important in the field of medicine?
Post market surveillance is extremely important because the device has been studied only in controlled environments. Patients who received the medical device during the clinical study usually fit strict inclusion criteria in the beginning phases, such as: being male, having no chronic health issues or having very specific indications. As the phases progress, the participating population pool grows. But it does not include the general public until post market approval or the post market “phase”. After approval and with the device available to the general population, physicians, healthcare workers, and patients who use this market approved device are able to report if any unseen complications or possibly life-threatening issues arise. Manufacturers are obligated to collect this data because in some cases, approved devices need to be pulled from the market after authorization due to safety concerns. Clinical studies before approval alone simply cannot predict the effect of a medical device on every individual medical device user.
Therefore, it is important to continue to incorporate the benefits of in silico and in silico clinical trials to a greater extent in the future. This makes it possible to cover a larger population from the beginning with less effort and to further increase the safety of medical devices.
How is Post Market Surveillance implemented by Simq?
Our medical simulation software solutions all generate digital evidence that is documented in a simulation report. This objective data generated with simulation adds another much needed facet to ensure the safety of the medical device and reduces the liability of the medical device manufacturer throughout the Post Market Surveillance period.
Why is Simq’s Post Market Surveillance particularly good and what added value does it create?
Simulation technology continues to advance and become an integral part of clinical studies. Simq also follows recommended Good Simulation Practices (GSP) which is on track to become a good practice quality guideline in the near future, and follows draft guidance from the FDA. When these simulation practices are enforced, we are ready, and therefore, our clients are ready.As mentioned above, Simq software provides a report automatically at the end of simulation, therefore eliminating the need to generate reports manually. We are in V&V40 working groups and always keep the reports up to date. Customized FDA compliant reports are also an available feature in our software solutions. These reports are ready for audits or inspections both internal and external.
What else should I know about Post Market Surveillance?
There are nuances between the FDA and MDR when it comes to Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF). For the MDR, PMS and PMCF are differentiated. PMS collects many types of data and PMCF collects clinical data to update the clinical evaluation. PMCF is treated by the MDR as a subset of PMS. If the PMS doesn’t present enough data or implies that changes need to be made to the clinical evaluation, PMCF may be required by the manufacturer.
The FDA requires the Post Market Surveillance to include Post Market Clinical Follow-up data, so these two terms (PMA and PMCF) are not differentiated.
Medical device manufacturers are increasingly being held more responsible for the outcome of their medical device designs. This can seem like a large task when a device is subjected to purely clinical observations and regulations from MDR and the FDA. Manufacturers need an objective way to prove the efficacy and quality of their product. Simq simulation software provides objective data for performance and safety evaluation on a scientific-biomechanical basis. This, together with clinical data, provides a robust evaluation of post market medical devices. This is the future, this is Simq simulation.