Updating Your Device In The EU? It Isn't Always Clear When You Need To Tell The Notified Body

In the EU, when do manufacturers need to tell notified bodies about an extension to their product line before placing the updated devices on the market? Is there a definitive answer, or is more clarity needed? Experts weigh in.

Business development idea and developing industry success through creative invention as a light bulb evolving to a gear shape as a 3D illustration.

Innovation in the medical devices sector is as much tied to incremental changes in product design as it is to ground-breaking new technologies.

But when does a change to an already marketed product, sometimes known as a line extension, need to go through the extra burden of being reviewed by a notified body...

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