[Eeglablist] active electrodes

[Alex Svojanovsky]

Dear EEGLAB List,
some comments from a manufacturer of active electrodes…:

The initial question/assumption was: “..my understanding is that none of the devices with active electrodes have any standard approval…(CE/FDA)”

Active Electrodes are electrically operated, so they can not be sold legally without a “standard approval”.

Within the EU, these products need to carry the so called CE mark and a declaration of conformity has to be issued by the manufacturer.
Here you can find a short overview about the (extremely comprehensive and detailed) regulation:
http://en.wikipedia.org/wiki/CE_marking

A manufacturer declares in his sole responsibility that the product complies with the applicable EU regulations/guidelines/standards.
The CE mark has to be present on the product and you should find this information on every manufacturer’s website.
(e.g. http://www.brainproducts.com/productdetails.php?id=42, click on technical specification tab and scroll down)

To mention other main manufacturers of active electrodes as well:
To my best knowledge, Biosemi and G.Tec (and we, Brain Products) all carry the CE mark on their products and sell their active electrode amplifiers with the “standard approval”, means they are CE marked.

In the US, the FDA is not really the exact counterpart, since FDA is a governmental institution which regulates the market (for similar and additional purposes).
Clinical products (or better: products which are intended to be used for medical applications) are under strict control of the FDA.
(So FDA is an institution whereas CE is the product marking as a result of the conformity evaluation process. FCC is kind of comparable to CE but originally/mainly for wireless products)

Research products (within the US) have to meet other regulations and are part of the IRB process which was mentioned already.

Medical products within the EU need to carry a 4 digit number next to the CE mark (e.g. CE 0123). The number indicates the Notified Body.
Products to be intended for research applications “just” have to carry the CE mark (without number) within the EU.

The CE-marking procedure was mainly established (besides other things) to increase product safety.

A related question to think of is:
Can I use a non-medical EEG amplifier (without medical CE) with active electrodes in my (University)Hospital (or medical environment) for sole research applications (within the EU)?
The European Court of Justice has decided: YES!

Hope this added value to the discussion.

Best regards,
Alex



Von: eeglablist-bounces at sccn.ucsd.edu [mailto:eeglablist-bounces at sccn.ucsd.edu] Im Auftrag von Makoto Miyakoshi
Gesendet: Donnerstag, 26. März 2015 20:14
An: Eriksen, Jeffrey :LGS Neurodiagnostics; geoff at emotiv.co
Cc: eeglablist at sccn.ucsd.edu
Betreff: Re: [Eeglablist] active electrodes

Dear Geoff and Jeff,

Thank you for your expert knowledge and quick responses!

> Any device which has US safety certifications and FCC Part 15 certification can be used safely on human subjects.
> Many EEG systems are sold in the USA with FDA clearance for clinical use

This is very good to know. Maybe my knowledge was based on very old information.

Makoto

On Thu, Mar 26, 2015 at 11:09 AM, Eriksen, Jeffrey :LGS Neurodiagnostics <JEriksen at lhs.org<mailto:JEriksen at lhs.org>> wrote:
Any and all:

FDA clears devices for general safety and efficacy for clinical use in the USA but does not care about research use. UL/CSA/ETC etc. certifies electrical safety specifically. You are covered legally for research use by your institutions IRB process, which should address the electrical safety issue and not care about FDA or clinical use.

In Europe I believe the CE regulates devices for general safety and efficacy, as well as electrical safety specifically, combining the roles of FDA and UL.

Many EEG systems are sold in the USA with FDA clearance for clinical use and that have up to 256 channels with electrode caps or nets that use variants of the 10-20, 10-10, or 10-5 system, or uniform geodesic spacing as the EGI produces. Some of these have active electrodes. Now it may be the case that the FDA does not clear any active electrode system for clinical use in the USA, but that has no impact on using them for research, as your IRB should take care of assuring their electrical safety.

-Jeff Eriksen
Portland, OR

From: eeglablist-bounces at sccn.ucsd.edu<mailto:eeglablist-bounces at sccn.ucsd.edu> [mailto:eeglablist-bounces at sccn.ucsd.edu<mailto:eeglablist-bounces at sccn.ucsd.edu>] On Behalf Of Makoto Miyakoshi
Sent: Thursday, March 26, 2015 10:31 AM
To: Friedman Doron
Cc: eeglablist at sccn.ucsd.edu<mailto:eeglablist at sccn.ucsd.edu>
Subject: Re: [Eeglablist] active electrodes

Dear Doron,

Interesting topic. I heard a rumor that the FDA-approved EEG recorder in US (I don't know which) supports only the classical 10-20 system channels... I could be wrong though. Anyone on the list please tell us what you know about this. I'm curious to know too. Thank you.

Makoto

On Mon, Mar 23, 2015 at 2:10 PM, Friedman Doron <doronf at idc.ac.il<mailto:doronf at idc.ac.il>> wrote:
Hi,

This is not directly related to EEGLAB but perhaps of interest to many of us: my understanding is that none of the devices with  active electrodes have any standard approval, such as CE (Europe) or FDA (US). Does that mean all of us who are using them in research labs are not covered legally? And what about commercial applications, such as neurofeedback?

Thx


-          d

Dr. Doron Friedman
Senior Lecturer
Sammy Ofer School of Communications
Office phone number: +972-9-9527654<tel:%2B972-9-9527654>
Room C225, Sammy Ofer building
The Interdisciplinary Center, Herzliya
PO Box 167, 46150

Director, Advanced Reality Lab
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--
Makoto Miyakoshi
Swartz Center for Computational Neuroscience
Institute for Neural Computation, University of California San Diego



--
Makoto Miyakoshi
Swartz Center for Computational Neuroscience
Institute for Neural Computation, University of California San Diego
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