Blogs
Here we provide you with key information related to the Medical Device and In Vitro Diagnostic (IVD) industry through Patient Guard’s blogs. We provide invaluable content that delves into the regulation and Quality Assurance of Medical Device and IVDs, with focus on navigating the regulatory landscapes of the United Kingdom (UK), the European Union (EU), and the United States (US).
At Patient Guard, we are not just a source of information; we are your ultimate partner in understanding and maneuvering through the complexities of Medical Device and IVD regulatory requirements, as well as Quality Assurance. Our blogs serve as a beacon, illuminating the latest updates and insights crucial for professionals and organizations operating in these highly regulated sectors.
Patient Guard is not just a repository of information; we are your ally in navigating the ever-evolving landscape of Medical Device and IVD regulations. Join us on this educational journey, where compliance meets excellence.
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The In Vitro Diagnostic Regulation (EU IVDR) 2017/746 has brought about a significant transformation in the regulatory framework for IVD devices across Europe. One of the most crucial components of this regulation is Article 10, which outlines the general obligations of manufacturers.
As IVD manufacturers work to meet new compliance expectations, understanding the structure and impact of Article 10 is essential—not only for regulatory approval but also for maintaining ongoing access to the EU market....
The European Union Medical Device Regulation (EU MDR) 2017/745 is a comprehensive regulatory framework that governs the safety and performance of medical devices in the EU market. Among its core provisions, Article 10 – General Obligations of Manufacturers – serves as a foundational pillar that shapes how manufacturers bring their products to market and manage them throughout their lifecycle....
The European Union Medical Device Regulation (EU MDR) has become a crucial framework for ensuring the safety and performance of medical devices in the EU market. For companies entering the medical device sector or seeking to comply with the latest regulatory requirements, understanding the fundamentals of MDR is essential. In this guide, we’ll break down the basics of MDR and what it means for manufacturers, importers, distributors, and authorised representatives....
Navigating the complex world of in vitro diagnostic regulations can be daunting, especially for those new to the medical device industry. The In Vitro Diagnostic Regulation (IVDR), introduced by the European Union, is a critical framework that ensures the safety, performance, and quality of in vitro diagnostic (IVD) devices within the EU market. This beginner-friendly guide breaks down the essentials of IVDR, offering insights on its key components, classification rules, and practical steps for compliance....
Welcome to our May 2025 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued....
Bringing a medical device to market in the European Union is a complex process. With the implementation of the EU Medical Device Regulation (MDR) 2017/745, manufacturers must follow a detailed regulatory roadmap to achieve CE marking and ensure continued compliance....
