Preparing For Post-Market Clinical Follow-Up Under EU MDR

The introduction of the European Union Medical Device Regulation (EU MDR) in the post-COVID era has instigated profound transformations in PMCF, resulting in stricter requirements. Manufacturers, as they prepare to meet these new mandates, must strategically align their efforts in PMCF data collection and compliance. The importance of this alignment cannot be overstated. With the appropriate resources, tools, and expert guidance, manufacturers can adeptly navigate these requirements, ensuring that their devices remain compliant and ready for the market in the post-COVID landscape.

However, it is also important for clinical data professionals who work on medical device studies to understand how to collect compliant data, as should regulatory affairs professionals seeking to improve their skills in the regulatory environment.

This whitepaper serves as a guide to comprehending the primary challenges faced by the industry's commercial model in response to the updated EU MDR guidelines. By addressing these transformative factors, teams will be equipped to construct an operational model for their business that is well-suited to the current demands.