UDI Explained: What Are UDI-DI, UDI-PI and the Basic UDI-DI?
Manufacturers operating across the EU, UK and USA quickly encounter a set of similar but distinct terms relating to Unique Device Identification (UDI). UDI, UDI-DI, UDI-PI and the Basic UDI-DI often cause confusion, and understanding their differences is essential for compliant labelling, packaging, regulatory submissions and traceability. This article breaks down each term clearly and […]
Clinical Evaluation Under EU MDR: When Can Equivalence Be Used?
Under the EU Medical Device Regulation (EU)2017/745 (EU MDR), clinical evaluation is a cornerstone of demonstrating that a medical device is safe and performs as intended. But the route to showing sufficient clinical evidence isn’t the same for every device. Depending on risk class, design history, and available data, manufacturers may rely on clinical investigations, […]
FDA Q Submissions: The Strategic Route to Smoother US Market Entry
Bringing a medical device to the United States presents a significant opportunity, but the regulatory pathway can be challenging, particularly for manufacturers new to the FDA process. Many companies preparing for a 510(k), De Novo, PMA or IDE underestimate the importance of early dialogue with the FDA. The Q Submission Program, commonly referred to as […]
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 […]