So, recently, I’ve attended quite a few webinars and virtual conferences, to refresh my regulatory intelligence activities, you know…
And what shall I say, the most frequent statement still seems to be that we are “still waiting for guidance”. This week, I’m attending the RAPS Euro Convergence and again I hear this statement often (too often?).
On the other hand, I’m also positively surprised by quite a few specific approaches and examples by some of the speakers. Yes, there is a lot of the “MDR will kill innovation and what MDR doesn’t kill, Covid will” attitude, but we also have a couple of brave approaches to be proactive and do with what we have and challenge the unknown. That’s the spirit!
Agreed, some of these approaches will fail, but what’s the alternative, really? Not submitting at all? Not an option, dear reader. Let’s try to have a bit more entrepreneurial spirit in RA. I know, I know, there are caveats to this approach, like writing documents into the unknown and having to update them as soon as a new guidance or new information comes out, or catching deficiencies for documents that are outdated because guidance came out during the review process and is immediately applied by the reviewer (not fair, but been there)… And the constant need for checking and rechecking the websites and feeds. On constant standby, which is very tiring in itself. To which you may say, that it’s been like this always in regulatory intelligence. But I would argue that the time intervals between new or updated pieces of guidance were longer, so there was more time to digest it and oftentimes a stronger basis on which guidance was built. For the MDR, any guidance that comes out seems too late by default, while at the same time we can’t wait another day to implement it, while at the same time we are realizing that something is still missing from the puzzle… And so we stay, on standby…
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