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A new (E)RA?

Regulatory Rabbit

No. I refuse to do it. Uh-uh. I will NOT complain once again about how dreadful and hopeless the whole situation with the MDR is. Not that I wouldn’t have so many things I could bring up to rant about. But I just don’t want to be this whining, complaining, do-nothing-about-it person that has nothing to contribute. Admittedly, those are a lot of negations, considering the fact that I was going to speak about something positive.

Regulatory rabbit

So. Dear reader, do you want to know what I actually like about the MDR? No, I’m not delusional and shutting myself out from reality, thank you very much! I’m serious.

What I like is that I actually get a LOT of stuff to clean out in our documentation. Man, have I cleaned out and harmonized formulations and arguments! And people now actually let me do it!! Because, mind you, dear reader, it’s not as if I had discovered these little (and bigger) flaws for the first time.

I have been telling people for years that we should change this and make that argument properly once and for all, or haven’t I? But now it’s different because people listen to me and they take and make time to adjust the documents and processes.

Unbelievable!! Like one happy unbirthday after the other, day after day. Of course, that’s only because at the moment there’s the MDR knowledge vacuum and no-one knows what’s coming their way, so they ask – and they even wait to listen for the answer (actually, sooo, sooo many questions to answer.. And that in a time where we count the (man) hours to the MDR DoA with remarkably much left to do and remarkably little knowledge around). There is indeed so much interest in what I (might) have to say to this and that that I’m always late for my appointments with the documents…

Me, the rabbit being in the spotlight of attention. Can you believe that? Because, let’s face it… people don’t always like to put me and my concerns first, because of bringing up all these tedious questions that only an outsider could ask. Like, an authority for example?! Or a patient? Or, worse, a lawyer? So usually, it’s like, “meet RA, likely to be the person who spoils all the fun for the enthusiastic R&D, sales and finance departments” (the latter, because RA doesn’t even have proper KPIs most of the time…).

And now.. The transformation. Meet RA, the one who might save the Tech File – and who might have an answer to these mind-twisting requirements that no normal person can understand (lawyers don’t count). And I certainly don’t always know the answer..

Regulatory Rabbit

But here we are, in a time in which recalling the information from the latest guidance is almost hip and small-talk worthy. Sounds too good to be true? Well, maybe, yes… Definitely to be continued!

Regulatory Rabbit