Remember when I wrote about us submitting a BfArM classification request? In the meantime, our request has been processed and we've received the result. It took 462 days.
Or, in German legal speak, because sometimes Germans like to spell out numbers:
Four hundred and sixty-two days.
For a MDR classification. Wow.
The actual response was.. rather unspectacular. It was 7 pages long, of which 1 page was mostly boilerplate. The remaining 6 pages contained a well-written and well-reasoned assessment on the classification of the device in question. It sounds a bit like the dude who wrote it had quite some subject matter expertise himself, so I really appreciate that.
They didn't decide in our favour. You might expect me to rant now, but I actually don't - their response was well-argued and I can understand their line of thought. It sounds better than mine.
And, you know, if it had not taken 462 days to write up and send us those 7 pages, I would actually be quite happy about this process!
But the fact that it took 462 is.. I don't know, I'm at a loss of words.
How should a company, any company, be able to conduct business operations if it has to wait 462 days for a decision regarding their medical device?
How should a startup operate if it has to wait 462 days for a decision on whether their medical device might be classified like they thought?
How should a country operate in a constructive way, if its businesses can't operate?
I don't know. You tell me.
As a side note, I'm not blaming the BfArM for anything here. In my experience with bureaucracy, when you go there, you'll likely find the typical "bureaucracy scenario" you encounter in so many state agencies in Germany: Super-friendly, competent people who are doing their best, bogged down by completely broken processes and busy filling out all sorts of paper forms and mailing letters. Weird requirements, either by the country, state, or the EU, which make it (much) harder for them to do their job. And probably terrible internal software.
But that's just my guess.
Or, in German legal speak, because sometimes Germans like to spell out numbers:
Four hundred and sixty-two days.
For a MDR classification. Wow.
The actual response was.. rather unspectacular. It was 7 pages long, of which 1 page was mostly boilerplate. The remaining 6 pages contained a well-written and well-reasoned assessment on the classification of the device in question. It sounds a bit like the dude who wrote it had quite some subject matter expertise himself, so I really appreciate that.
They didn't decide in our favour. You might expect me to rant now, but I actually don't - their response was well-argued and I can understand their line of thought. It sounds better than mine.
And, you know, if it had not taken 462 days to write up and send us those 7 pages, I would actually be quite happy about this process!
But the fact that it took 462 is.. I don't know, I'm at a loss of words.
How should a company, any company, be able to conduct business operations if it has to wait 462 days for a decision regarding their medical device?
How should a startup operate if it has to wait 462 days for a decision on whether their medical device might be classified like they thought?
How should a country operate in a constructive way, if its businesses can't operate?
I don't know. You tell me.
As a side note, I'm not blaming the BfArM for anything here. In my experience with bureaucracy, when you go there, you'll likely find the typical "bureaucracy scenario" you encounter in so many state agencies in Germany: Super-friendly, competent people who are doing their best, bogged down by completely broken processes and busy filling out all sorts of paper forms and mailing letters. Weird requirements, either by the country, state, or the EU, which make it (much) harder for them to do their job. And probably terrible internal software.
But that's just my guess.
