The ECG/EKG availability in the EU?

[RB_Swe]

Will the ECG/EKG be activated in the EU at all?

If its going to be activated, does anyone know when?

[N8teGee · Accepted solution]

Hi @RB_Swe, good to see you in the community.

Currently it appears to be awaiting CE approval for use within the EU. No one really knows how long this might take, hopefully it won't be a long wait. 

FDA review of compatible ECG app pending; only available in the U.S. upon clearance. Availability outside the U.S. pending applicable regulatory clearances including approval under Directive 93/42/EEC (the Medical Device Directive). The ECG app has not yet received a CE mark and will not be marketed, put into service or otherwise made available in the EU until it has obtained regulatory approval. Not intended for use by people under 22 years old. See www.fitbit.com/ecg for more details.

[Marrrmaduke]

@RB_Swe don't quote me on the exact date but it's in the works. Might be early next year. Fingers crossed.  

Read me 🙂 

[Julia_G]

I would not expect this feature in the near future.  Fitbit have not confirmed that the application for approval has even been submitted.

[Marrrmaduke]

@Julia_G actually Fitbit confirmed. Click on the link in my prev post. 😍

[Julia_G]

I have read that article, and it doesn’t look like confirmation re the EU to me.  I would be surprised to see it there any time soon.  But I hope I am wrong and you are right.

[Marrrmaduke]

I have high hopes as it came from VP Product of Fitbit. 😍

[RB_Swe]

Please note now that UK has left the EU, a CE approval mark on the device might not be accepted by UK authority anymore.

[Julia_G]

@RB_Swe that will no doubt be part of the ongoing negotiations, but I am guessing that CE will continue to be accepted.  The EU is still the UK’s biggest trading partner and CE is not among the contentious issues.

[RB_Swe]

”The UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. The Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed that, during this transition period, the UK will stay aligned to EU law. The transition period is due to end on Thursday 31 December 2020.”

(https://www.bsigroup.com/en-GB/medical-devices/news-centre/enews/2020-news/post-brexit-update-on-the... )

So, Fitbit is in a hurry to get the CE approval before 31 december 2020, or they might have a problem on the UK market depending on the result of the BREXIT negotations?

[N8teGee]

So it appears that this has now been approved within the EU, with hopefully an October launch.

https://www.wareable.com/fitbit/fitbit-sense-ecg-clears-fda-ahead-of-launch-8084 

[Maneetti]

Hi, This is great news (old news) this is still not available in EU for expample in Finland can fitbit remove the restriction in all EU countries.

EDIT: according to this blog post ECG is now approved by EU so now you can enable it in all EU member states? Fitbit gains US, Europe clearance ECG app to identify AFib (blog.google)