ECG in Germany

When will ECG be finally available in Europe or Germany for the Epix Pro 2? I find Garmin's information policy frustrating. There is no rational reason why Garmin cannot announce that they are, for example, working on a release in the spring. Other manufacturers do that after all. Apple took three months, why does it take so long with Garmin? I fear it will be treated similarly neglectfully as Garmin Pay.

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bluefish over 1 year ago +2

UFFDADA73 said:
There is no rational reason why Garmin cannot announce that

ECG must undergo an approval process. The rules for this are different in each country. As long as there is no approval, you…

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0 bluefish over 1 year ago

UFFDADA73 said:
There is no rational reason why Garmin cannot announce that

ECG must undergo an approval process. The rules for this are different in each country. As long as there is no approval, you will not receive any information about when it will be available in your country.

0 UFFDADA73 over 1 year ago in reply to bluefish

As I have already written, there is no such restriction. Other manufacturers announce the imminent availability... if they plan it... ;-)

0 bluefish over 1 year ago in reply to UFFDADA73

UFFDADA73 said:
Other manufacturers announce the imminent availability... if they plan it... ;-)

Not if they plan it. When they have received approval from the licensing authority.

0 bluefish over 1 year ago in reply to UFFDADA73

bluefish said:
ECG must undergo an approval process.

UFFDADA73 said:
As I have already written, there is no such restriction.

Why Apple needed the FDA to sign off on its EKG but not its blood oxygen monitor

https://www.theverge.com/2020/10/7/21504023/apple-watch-ekg-blood-oxygen-fda-clearance

0 bluefish over 1 year ago in reply to UFFDADA73

UFFDADA73 said:
As I have already written, there is no such restriction.

https://www.dcrainmaker.com/2023/01/garmin-ecg-app-devices-fully-explained.html

0 bluefish over 1 year ago in reply to UFFDADA73

UFFDADA73 said:
As I have already written, there is no such restriction.

UFFDADA73 said:
When will ECG be finally available in Europe or Germany for the Epix Pro 2?

German Article :

Wann kommt die Garmin EKG-Funktion in die EU und Deutschland?

…“Wie oben angerissen, ist die EU-Zulassung hier der Flaschenhals und eine der Hauptursachen für die Verzögerung der Einführung der EKG-Funktion in den Garmin-Uhren. Konkret ist es die obligatorische CE-Kennzeichnung nach der Medizinprodukterichtlinie 93/42/EWG. Diese behördliche Genehmigung ist ein unumgänglicher Schritt, den alle Hersteller gehen müssen, wenn sie in ihrem Produkt eine EKG-Funktion anbieten möchten. Es ist allerdings nur eine Frage der Zeit, bis Garmin die Zulassung erhält.“…

In welchen Ländern bietet Garmin die EKG-Funktion an?

…“Die regionale Verfügbarkeit bleibt auch im Oktober 2023 noch beschränkt. Auch wenn viele fragen, bleibt die EKG-Funktion vorerst nur in den USA, Hongkong und Vietnam verfügbar. Für Europa oder Australien gibt es aufgrund des noch laufenden Zulassungsprozesses noch keine konkreten Termine,“…

https://fitnessmodern.de/garmin-ekg-uhren/

0 Siege1968 over 1 year ago

Google the topic 'Garmin ECG in Europe'. The first hit should be of interest to you.
Duration of the procedure, 5 minutes, worked wonderfully...

0 John over 1 year ago in reply to bluefish

ECG measurement is medical device. Both in EU and US medical devices are regulated. those regulations are not harmonized.

for the EU the Medical Device Regulation (2017/745) applies. This is a tedious process.

My key question is why you would like to have a single lead derived ECG anyway. I don't see any benefit over regular pulse HR.

0 UFFDADA73 over 1 year ago in reply to Siege1968

Belief is not knowledge. What self-proclaimed experts interpret from Garmin’s silence is not factual. The information policy of Garmin remains poor compared to other manufacturers. Those who wish to gloss over this are free to do so.

0 John over 1 year ago in reply to UFFDADA73

What is weird about not offering ECG in Europe (yet?) and not advertising that? The regulations are clear. And if you do not comply with the regulations (yet?) then that is the way it is.

Still, the fundamental question is what single lead ECG really means to a lay man (and even to a medical professional..).