FDA 510(k) vs. PMA: Understanding the FDA’s Medical Device Approval Pathways
FDA 510(k) vs. PMA: What’s the Difference? If you’re preparing to bring a medical device to the U.S. market, understanding the differences between FDA 510(k) and Premarket Approval (PMA) is critical. These two regulatory pathways serve different device classes, timelines, and evidence requirements. In short: What Is FDA 510(k)? The FDA 510(k) process (named after […]
Clinical Evaluation for EU MDR: A Step-by-Step Guide to CE Marking
Clinical evaluation is one of the most important processes in bringing a medical device to market in the EU. As a regulatory requirement under the EU MDR 2017/745, it ensures your device is clinically safe and performs as intended — and is essential for achieving CE marking. But where do you start? Below is a […]
Performance Evaluation for IVDs Under IVDR: Key Areas You Must Cover
What is the IVDR Performance Evaluation? Under the IVDR Regulation (EU) 2017/746, all In-Vitro Diagnostic devices (IVDs) must undergo a thorough Performance Evaluation before being placed on the market. This evaluation ensures that the devices meet safety, accuracy, and effectiveness standards for their intended use. Detailed requirements for carrying out a Performance Evaluation Plan (PEP) […]
European Regulations for Companion Diagnostics (CDx): Navigating the CE Marking Pathway to Market
Companion diagnostics (CDx) are increasingly critical in personalised medicine, offering vital insights into patient treatment and outcomes. With the rise of these devices, navigating the European Union In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) has become essential for manufacturers. CDx devices must undergo a conformity assessment by a notified body to obtain CE […]
Step-by-Step Process: How to Conduct a Performance Evaluation for your In Vitro Diagnostic Device
What is Performance Evaluation and Why is it Important? Under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), all In Vitro Diagnostic (IVD) devices must undergo a Performance Evaluation before they are placed on the market. This process is a continuous one, conducted throughout the device’s lifecycle, ensuring that it remains safe, accurate, […]
Understanding Regulatory Intelligence in the Medical Device Industry
The Growing Importance of Regulatory Intelligence With regulatory requirements continuously evolving and the increasing stringency of medical device legislation, it’s no surprise that regulatory compliance can feel overwhelming, especially for manufacturers managing multiple markets. While Regulatory Intelligence (RI) may appear simple for low-risk devices such as Class I non-sterile products, the process becomes significantly more […]