ECG availablility in EU

[Ururebane]

Hello, I am considering jumping back to Google/Fitbit ecosystem but, I see that there are still unanswered questions as Fitbit/Google does not consider all EU countries equal. Based on the ECG App availability in Sense thread, which goes back years and comments are disabled  I see there are generic answers by Fitbit pointing to the same document twice without any deadlines. What are the plans for Charge 6? As I saw Charge 6 did not bring back elevation tracking, which is sad story for outside runners, what is the blocker bringing ECG to whole EU? There should not be any problem on limitation based on this documentation: https://blog.google/products/fitbit/fitbit-sense-ecg/

[N8teGee]

Hi @Ururebane.

It's a good question really. One would think regulatory approval would be handled collectively within the EU. Perhaps it could be as trivial as writing the supporting documentation in the appropriate language for each country, but that's only I guess. 

Unfortunately I don't think anyone from Fitbit would have any other response or explanation other than referring to the document you posted above. It would be nice if things were a little more open, but Fitbit have been this way for as long as I can remember. 

[RiekoC]

Hello @Ururebane 

I retired from the pharmaceutical/medical device manufacturing industry and have some insight to share. 

Although a drug or medical device can get approval from the European Medical Agency, many EU countries also require approval from their own country's regulatory agency before it is allowed to be sold/used. This requires a separate submission to that country's regulatory agency and can be an involved, lengthy process even for something that seems simple, like the Fitbit ECG app. The submission also requires a fee to be paid by the submitter. 

The holdup for using the Fitbit ECG app in a specific country might be due to that country's regulating body, rather than Fitbit not filing for authorization/approval. I also wonder if it could be Fitbit/Google determining that it's not economically feasible to submit for authorization/approval in a country that doesn't have sufficient sales to justify the cost. Unfortunately, there isn't a way that I've seen to determine the reason for the holdup. 

[Ururebane]

Should not be an issue here as most countries follow EU. I personally think Fitbit just does not care and uses lowest effort possible to go largest markets.