2024 - The Power of Clinical Data: Why Strategic PMCF Studies Matter

Post-market clinical follow-up (PMCF) studies are necessary for continuously monitoring the clinical benefits, performance and safety of a medical device once it is released on the market. As part of a broader post-market surveillance (PMS) strategy, these studies are crucial for assessing the long-term behavior of the device and ensuring that the risk–benefit profile remains favorable when the device is used as intended.
In addition to satisfying regulatory requirements under the EU Medical Device Regulation (MDR), these studies may even support opportunities to expand both markets and labeling and allow the collection of real-world evidence to inform reimbursement programs.
While the specific requirements for PMCF activities may vary based on the type of device, its intended use and the associated risk, clinical investigations are the most robust activity for assessing the ongoing performance and safety of a device. Developing a comprehensive PMCF plan as part of a PMS strategy early in the device lifecycle helps ensure efficient design and implementation of these investigations to maximize study outcomes and address multi-stakeholder requests.
Register for this webinar to explore key regulatory and clinical considerations for PCMF investigations under EU MDR.
Keywords: Medical Device, Clinical Data, Regulatory, Regulatory Compliance, Diagnostics, Medical Device Regulation, Post Market Surveillance, Commercialization/HEOR/Market Access, Toxicology/Safety