As a manufacturer, why should we bother to figure out how the MDR and IVDR will be interpreted by the NB's? Why not just give our noncompliant documentation to the NB, let them tell us what's wrong and then we'll do it? Hear the answer from former BSI Head of Global Clinical, Amie Smirthwaite

The NBs are now limited in the number of rounds of questions, so essentially if you do that you are wasting one round of questions. And then when you provide the information that they want, and you’re going to get more questions, so the possibility of failure is much greater. There is also pre-submission checks now, so they’re going to do a sanity check that is a bit more intense than it has been in the past, so chances are it might even get rejected at that sanity check stage.


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