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.
Categories
2026 represents a significant milestone for the amended IVDR transitional provisions framework....
If you sell cosmetics in the UK or EU, you are legally required to maintain a Cosmetics Product Information File - even if you’re a tiny indie brand mixing batches between client emails.
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ISO 15223-1:2025 is the kind of update that looks “small” on paper and then detonates in an audit because it’s printed on every box you ship.
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Home testing kits may seem like consumer products with sleek packaging, simple instructions, and sold online or in pharmacies. However, under EU law, they are some of the most tightly regulated diagnostic devices on the market....
A poorly structured medical device technical file is one of the fastest ways to trigger audit findings, Notified Body delays, or regulatory pushback, even when all the “right” documents technically exist.
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IVDR has fundamentally reshaped the regulatory landscape for in vitro diagnostic devices, and, yes, it’s still catching many manufacturers off guard years after its implementation.
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