It is often unclear as to when a notified body needs to be informed when updating your device in the EU

Innovation in the medical devices sector is as much linked to incremental changes in product design as it is to revolutionary new technologies. But when does a change to a previously marketed product, also known as a line extension, need to go through the extra obligation of being reviewed by a notified body before being placed on the market? And, then again, when can manufacturers place the product on the market without prior notification to a notified body or prior review and reveal the change at the next audit?

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Posted on 3. November 2017
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