After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you through this substantial document in a number of blogs, of which this is the first.
Some history
But first, for those who are not familiar with the Blue Guide, a little bit of history:
“The Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) was published in 2000 [...]
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