Medical Device Recalls, MDR Reporting, Imports and Exports, What Manufacturers Must Know
Understanding FDA medical device recalls, Medical Device Reporting obligations and the import and export rules that govern device movement across borders is essential for any manufacturer operating in the United States. These regulatory requirements exist to protect patients and preserve the integrity of the healthcare system, but they also pose operational and commercial risks when […]
FDA De Novo Process: A Clear Guide for Novel Medical Devices
The FDA De Novo pathway provides a structured route for novel medical devices that have no valid predicate but whose risk can be appropriately controlled through general controls or a combination of general and special controls. It is a classification mechanism designed for devices that do not fit within any existing Class I or Class […]
FDA Medical Device Classification and 510(k) Exemptions Explained
Understanding how the FDA classifies medical devices is essential for any manufacturer planning to enter the United States. Classification determines the regulatory controls that apply, the premarket submission required and the level of evidence the FDA expects. It also influences commercial strategy because timelines, cost and feasibility vary significantly between classes. The transcript outlines the […]
Proposed EU MDR and IVDR Changes, What the Reforms Mean for Manufacturers
The European Commission has proposed the most significant amendments to the EU Medical Device Regulation and In Vitro Diagnostic Regulation since their entry into force. These changes are intended to correct well-documented implementation challenges, reduce unnecessary regulatory burden, improve predictability and protect patient access, while maintaining high standards of safety and performance. For manufacturers, the […]
EU MDR/IVDR Technical File vs FDA Device Master Record: What Manufacturers Need to Know
Medical device manufacturers expanding into both the European Union and the United States often face a familiar question: Are the EU MDR/IVDR Technical File and the FDA Device Master Record (DMR) the same thing? At first glance, both sets of documentation describe how a device is designed, manufactured, and verified for safety and performance. Yet […]
The Risks of Misclassification in Medical Devices: Why Getting It Right Matters
Correct classification is the foundation of medical device compliance. It determines the regulatory pathway, the level of scrutiny, the depth of technical documentation required, and the evidence needed to demonstrate safety and performance. Both the MHRA and EU authorities are ramping up oversight and identifying more products on the market that do not meet the […]