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Happy New Year, anyone?

Regulatory Rabbit

Here it is upon us, the New Year. And I wonder. Will it be happy? Will we be happy? And if so, how – and when?? I want to be very honest with you, dear reader. For me, 2020 feels like waking up with a big, fat… hangover. Just this feeling of having been pumped* about something (aka MDR in 2019) before, and now just feeling this emptiness and headache, and not getting what all the fuss was about. Unfortunately, it’s a hangover that seems to have decided to stay.

Seriously, I’ve been back to the office for nearly two weeks now and there has been absolutely nothing that could be, even remotely, termed progress. No news from our Notified Body. No. Not even one of these “hang-on-we’re-nearly-there” emails they used to send all the time. No significant news from MDCG, no further corrigenda (ok, I’m joking now).

Just me, sitting at my desk, busily filing and piling on our submissions. Including the MDR submission, of which we do not know when we will be able to submit it. Please note that I’m using “when” instead of “if” with the maximum of optimism I can muster right now.

So, yeah, not directly circumstances under which you leave the office feeling fulfilled at the end of the day, or start a new day with a feeling of purpose. Plus, everyone around me has the same hangover attitude (and face!!).

Thinking about this makes the headache worse so I’ll stop.

Regulatory Rabbit

The optimists among you may say that every new year starts with a headache and the reflection on the last year (and, being human, we like to focus on the negative), but I disagree. This is not the general “New Year’s hangover”…

Regulatory Rabbit

Possibly because there is this existential dread that is mixing into it. 2020 is here and everyone, from MedTech Europe to my office mate is pretty sure that the year is off to a bad start and not expecting anyone to deliver on their promises.

*not necessarily in a good way, but at least with some energy

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


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