Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation? Clinical Study vs. Clinical Evaluation: An Overview If you’re in the medical device industry, you’ve probably come across the terms Clinical Study and Clinical Evaluation more than once. While they might seem similar, they serve different purposes and are used in different situations. Understanding these differences is crucial, especially when navigating regulatory requirements for market approval. So, let’s break it down in a simple and practical way—no heavy jargon, just the essential information you need! What is Clinical Study? Imagine you’re developing an innovative medical device—one that’s never been used before or has limited existing data on its safety and performance. Regulators will likely require a Clinical Study to gather fresh data on how the device works in real-world conditions. A Clinical Study involves testing the device on human participants to collect primary data on its safety, efficacy, and performance. This step is often mandatory for cutting-edge medical devices, especially in strict regulatory markets like the EU and the US. When Do You Need a Clinical Study? ✔ When launching a new or innovative medical device ✔ If there’s insufficient existing data on safety and effectiveness ✔ When entering highly regulated markets like the EU under MDR 2017/745 🛑 Key Point: Clinical Studies take time and require significant investment, but they’re necessary to prove that a device is safe and effective before it reaches patients. What is a Clinical Evaluation? Now, let’s say your device is not entirely new, and there’s already relevant clinical data available—perhaps from previous studies, post-market surveillance, or real-world use. Instead of conducting a full-blown Clinical Study, you might only need a Clinical Evaluation. A Clinical Evaluation is the process of analyzing existing data to demonstrate that your device meets safety and performance standards. It doesn’t involve new human trials but instead gathers information from scientific literature, market data, and historical performance records. For more information visit - https://acplgroupindia.co.in Call – 9266665201 info@acplgroupindia.co.in