07-17-2023 05:29
07-17-2023 05:29
Answered! Go to the Best Answer.
07-17-2023 07:34
07-17-2023 07:34
Unfortunately Denmark is not on the most recent list published in the Fitbit store:
“The ECG app is available on Fitbit Sense 2, Fitbit Sense and Fitbit Charge 5 in the following countries:
American Samoa ᐧ Australia ᐧ Austria ᐧ Belgium ᐧ Canada ᐧ Chile ᐧ Czech Republic ᐧ France ᐧ Germany ᐧ Guam ᐧ Hong Kong ᐧ India ᐧ Ireland ᐧ Italy ᐧ Luxembourg ᐧ Netherlands ᐧ New Zealand ᐧ Norway ᐧ Poland ᐧ Portugal ᐧ Puerto Rico ᐧ Romania ᐧ Singapore ᐧ South Africa ᐧ Spain ᐧ Sweden ᐧ Switzerland ᐧ United Kingdom ᐧ United States ᐧ U.S. Virgin Islands”
This is due to regulatory issues in each country. Hopefully Denmark will soon join other European countries in approving this, but it is out of Fitbit’s control.
I am sorry not to have better news for you at this stage, but welcome to the Community Forums nevertheless.
Sense, Charge 5, Inspire 2; iOS and Android
07-17-2023 07:34
07-17-2023 07:34
Unfortunately Denmark is not on the most recent list published in the Fitbit store:
“The ECG app is available on Fitbit Sense 2, Fitbit Sense and Fitbit Charge 5 in the following countries:
American Samoa ᐧ Australia ᐧ Austria ᐧ Belgium ᐧ Canada ᐧ Chile ᐧ Czech Republic ᐧ France ᐧ Germany ᐧ Guam ᐧ Hong Kong ᐧ India ᐧ Ireland ᐧ Italy ᐧ Luxembourg ᐧ Netherlands ᐧ New Zealand ᐧ Norway ᐧ Poland ᐧ Portugal ᐧ Puerto Rico ᐧ Romania ᐧ Singapore ᐧ South Africa ᐧ Spain ᐧ Sweden ᐧ Switzerland ᐧ United Kingdom ᐧ United States ᐧ U.S. Virgin Islands”
This is due to regulatory issues in each country. Hopefully Denmark will soon join other European countries in approving this, but it is out of Fitbit’s control.
I am sorry not to have better news for you at this stage, but welcome to the Community Forums nevertheless.
Sense, Charge 5, Inspire 2; iOS and Android
07-18-2023 07:30
07-18-2023 07:30
Do you whether there is an application pending? Is Fitbit awaiting the Danish authorities? I am little puzzled that other European and Scandinavian countries have approved while Denmark hasn’t seems unrealistic.
07-18-2023 09:58
07-18-2023 09:58
I am afraid I don’t have that information. My understanding is that Fitbit applied to the EU regulatory authorities and were given approval, but it seems that individual countries also needed to accept the general approval and for some reason Denmark has not.
Sense, Charge 5, Inspire 2; iOS and Android
07-18-2023 11:21
07-18-2023 11:21
I don't know, but now I am returning the watch as the ECG app was the reason I bought it in the first place.
07-18-2023 11:43
07-18-2023 11:43
Hello & welcome @MLvL and @tharuman
I worked in the pharma industry. Getting approval from the European Medical Authority (EMA) is the first step in order to sell in the European market. However, each country that has a Health Authority still has to approve and that takes time. I've seen where this can take a year or more.
You might want to consider visiting the product community sites to confirm that features like ECG have been approved for that device in Denmark as you look for a different health tracker.
Rieko | N California USA MBG PE
07-18-2023 12:07
07-18-2023 12:07
Hi Rieko, thanks for answering.
Since it’s approved in Sweden and Germany I assume that the EMA approval is in place and since Denmark, Norway and Sweden typically have the same rules I’m just curious on whether its pending the Danish authorities or Firbit to take action.
07-18-2023 12:28
07-18-2023 12:28
Hi @tharuman
I tried to do a quick search to see if Fitbit has submitted for approval in Denmark, but didn't find anything. One would think that if it's been approved by Sweden & Germany, it shouldn't be too difficult to get approval in Denmark. As I recall, getting approval by Germany's Health Authority is a big milestone for the European market since Germany's HA tends to be on the stricter side.
Rieko | N California USA MBG PE
07-18-2023 14:41
07-18-2023 14:41
Wow, thanks for looking into this. And yes I would think the same. Do you have an idea how to ping the fitbit team about this?
08-02-2023 13:28
08-02-2023 13:28
Hi Julia
thanks for your explanation but I’ll still recommend if Fitbit can check with Danish health authorities for approval of using ECG app. I can see other companies like Samsung and Apple have this approval and their ECG app is functional in Denmark.
hope you guys will look into it again.