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On and on we go?

A hectic Regulatory Rabbit

My work life has made an interesting development indeed, dear reader. It is both hectic and boring at the same time. Hectic because of so much new guidance and dynamic developments that I have to and want to follow all the time. Nearly feels as if I cannot focus or finish anything these days because the next thing to be evaluated, read and interpreted is already around the corner. Always late, always late for a very important date 😉

A bored Regulatory Rabbit

And booooring because it’s always around these two topics: MDR and COVID-19. In the EU, no other topic than MDR exists – unless it’s MDR considerations around COVID-19 maybe? And the FDA is really only concerned with COVID-19, their emergency use approvals and guidance for any device or test or what-have-you around devices and medication for… SARS/Cov-2/COVID-19.

I get that. Totally. That is very, very important. But the amount of guidance (and tests and devices) they are putting out is nearly unbearable. I really don’t know if we need so many different tests and devices? And all of them at the same time, too? I’m sure it’s all meant well, but at the moment it’s just a tad out of control, isn’t it. And that’s me saying that, being a fan of the 510(k) program and working on me-too devices most of the time.

It’s just that, at the same time, other things are still happening, and we might just not be seeing them anymore in this fog. What I used to like about my job is that it’s so international and that you get to see so many different country regulations and approaches. Not anymore I guess.

So, what else? Well, while we’re speaking of it… Regulatory Rabbit is packing its bag (or backpack as I bike to work) to leave this place. As always, there are many reasons, big and small. I guess most of all, I just felt unfree for some time now. I could see everything moving in its well-established patterns, the same political bickering between the departments, the same “we’ve always done it like this” like the well trained dance steps of an ageing dance couple. And all of us going in the same circles, round and round. And the nerve-racking waiting for our notified body MDR designation.

OK, it would go too far to link my resignation letter to our notified body. But man, they have racked my nerves indeed. Anyways, on to new shores!

Wish me luck 🙂

Regulatory Rabbit

Say goodbye to wasting time and money on digitising your regulatory activities.


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