Within the new, stricter European Medical Device Regulation (EU-MDR), which will now come into force on the 26th May 2021, there is more emphasis on a life-cycle approach to safety, backed up by clinical data and post-market monitoring. Post Market Clinical Follow-up (PMCF) falls within the Post Market Surveillance (PMS) plan and will require manufacturers to not only reactively assess the safety and performance of their devices, but they will also need to pro-actively assess and record this data throughout the product’s lifecycle.
Although randomised clinical trials and registries provide higher levels of evidence, they may not be possible for certain devices. On the other hand, end-user surveys require less work, money and time.
GEMARMED has developed a best-practice approach for PMCF Studies or PMCF Plans, approved by EU regulators and compliant with GDPR regulations, to pro-actively assess the experience of customers with your medical device, for inclusion in your PMCF submission.
We have already completed more than 100 bespoke PMCF surveys for some of the leading medical device manufacturers.
GEMARMED can help support you with the design, implementation, data collection and reporting of your PMCF surveys. Make sure that you have everything in place to be compliant with the EU-MDR, today.