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Never give up!

Regulatory Rabbit

11:45, my office. I’m sitting at my desk and quite busy compiling away on a submission when something in the corner of my eye catches my attention.

It isn’t really that anything was moving over there. I just felt the ominous presence of a very dark cloud lurking nearby. I look over. Aah, yes, my MDR pile! Just sitting there and not doing anything, really. Just a pile. Just the stuff that I found interesting enough to print out. Not too large. Maybe even too small? Now it sits there. If it had eyes, it’d be staring at me! Waiting to be read (hey, wait, I did that already!). And be read again (did that, too). And be implemented (started that, then realised I was lacking some important details). So why even bother when I actually have a ton of stuff to do (MDD, mind you). I shouldn’t be bothered.

But I am. Oh, yes, thank you very much, I know that I have to prepare. Or be prepared, by now. Because the transition deadline to MDR is actually months (feels like days), not years away and we’re still running on MDD (exclusively). And in a few months we’ll have to switch to MDR, more or less from one day to the other. At least that’s how it’s going to feel (I assume).

We’ll just go from one massive quality manual document to another. Sure. Exchange all the relevant SOPs and documents to the MDR requirements, and that’ll be it?! On we go as it is defined and laid down in the manual. Easy Peasy! Really? But… we have only drafts of SOPs sitting. Drafts with gaps and comments (“waiting for guidance on whether this will fully apply) and empty fields to be filled.

And mind you, no one seriously asks me about finalisation of these drafts as we’re all busy with our day to day routines.

Regulatory Rabbit

When I turn to Dr. google to the rescue, I find that either no one had thought about what I was looking for, or someone had, but had only received answers like “.. we don’t yet know. Why don’t you put a titled, but otherwise empty field, just so you can show the auditor that you thought about it”. Wow. I mean, think about things all the time, but is that nowadays sufficient to satisfy requirements? Are we talking wishful thinking or facts? At least facts are starting to drip in now, like long awaited information on Basic UDI-DI (one field down, at least theoretically…).

medical device regulation

Still bothered. Not because there is a lot of work to do. Not because there are new requirements. That’s how it always is (also, if there were no new requirements, I’d probably be out of my job). I’m bothered by the lack of details and how to’s, and basically how unprepared the whole system is.

Thought experiment. Let’s assume, I wanted to become MDR compliant now. Say, I had everything in place and implemented. Could I become certified? Nope. Because our notified body hasn’t been designated, yet, and in fact, I don’t even know IF they will be and when (and for which scope, to make things even more interesting). And I also know that there are the first notified bodies that are designated and even companies and products that have made it to MDR-land and that’s great – but that’s just not us. Look, I won’t even get started on the notified body situation, because there’s nothing I can change about it. Finger pointing doesn’t help with implementation of the MDR either.

career tips on MDR and IVDR

In fact, at the moment, nothing really helps me with the implementation of the MDR, other than wait and screen for new and potentially helpful information and confirmation. If someone comes and asks me how MDR is going I tell them, we’ve done the gap analysis, we have a list and timelines and deliverables defined and we have our drafts. And we just have to wait for more information on some of the details and news from our notified body. By the way, when I ask my line manager, this is the exact response I get.

And anyway, apart from that, we have zero time to focus anymore on MDR than we have to focus on all the other topics at hand, urgent missions from production or sales and other departments. MDR is the topic for lunch and coffee breaks, and that’s not because we don’t want to talk about it, but because there are still so many gaps, as in knowledge gaps – What?

Oh, yes, Ben is asking about lunch. I guess I get to discuss some MDR now. And then maybe go through that pile and the internet once more in search of more implementable details? Take a deep breath. And never (ever) give up!

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