The BfArM Processed Our Classification Request, And It Only Took 462 Days

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.

On a different note: Do you still have lots of questions about the EU MDR and would you like to talk to a human? No worries! We offer our Regulatory Strategy Workshop to companies like yours, in which we sit down with you for two hours, answer all your questions and come up with a plan with which you’ll bring your product to market. For only 400€!

Or, if you don’t like talking to humans, check out our Wizard instead. It’s a self-guided video course which helps you create your documentation all by yourself. No prior knowledge required.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to automate your compliance, look no further. We’ve built Formwork, and it even has a free version!

And finally, if all of this doesn’t sound helpful and your situation seems hopeless, check out our consulting 🙂

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