EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]

EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]If you are developing a new medical device for sale in the EU, the EU MDR update affects you as you must now get it certified to the EU MDR regulation. 

But what is the path to get it certified? It very much depends on its ‘class’. 

In a previous article, we explained how to confirm if your product is considered ‘medical’ in the European Union. We also described the logic applied to determine how medical devices are classified.

In this article, let’s look at the path to certification for the different classes of medical devices in this new EU MDR update.

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