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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Personal Protective Equipment (PPE) plays a vital role in keeping workers safe across many industries. From healthcare and construction to agriculture and manufacturing, PPE is used to reduce exposure to hazards that can cause injury or illness....
The European Union Medical Device Regulation (EU MDR) 2017/745 significantly reshaped the regulatory landscape for medical devices in Europe. One area that continues to cause confusion for manufacturers, distributors, and assemblers alike is the regulation of system and procedure packs. These are specific types of medical device groupings that, while not always requiring full CE marking as a new device, are still tightly regulated under Article 22 of the MDR....
If you're entering the medical device market or managing regulatory compliance for the first time, one term you'll hear frequently is UDI – Unique Device Identification. This system is critical to global regulatory frameworks and is rapidly becoming a non-negotiable requirement for manufacturers worldwide.
In this comprehensive beginner’s guide, we’ll explain what UDI is, why it exists, how it works, what the regulatory requirements are in major markets, and how to implement it effectively within your organisation. We’ve also included answers to some frequently asked questions to help clarify common uncertainties....
Welcome to our June 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....
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....
