Classification of ECG/EKG Electrodes according to MDD 93/42/EEC?

A

asimuh

#1
Does anyone knows, which classification rule applies to the ECG/EKG Electrodes? Is the right classification class I or class IIa?

According to the medical device manufacturer they shall be classified as class I based on rule 12 (from annex IX, MDD 93/42/EEC).

However our auditor it is class IIa based rule 10 (from annex IX, MDD 93/42/EEC).

At a different medical device manufacturer, I have discovered that they also classify these electrodes as class I.

The manufacturer have classified the electrodes as class 2 in Canada.

I would appreciate if anyone can provide any guidance on this.

Thanks in advance.
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
Can you please tell the intended use of your product ECG/EKG electrodes?. The classification may vary depend upon the intended use of the product..

Non-invasive electrodes (electrodes for EEG or ECG) are fall under class I as per rule 1 of MDD 93/42/EEC

Electrodes for electrophysiological diagnosis and ablation will fall under class III as per Rule 6 of MDD 93/42/EEC

Cortical electrodes are fall under class III as per rule 7 of MDD 93/42/EEC

CNS electrodes are fall under class III as per rule 8 of MDD 93/42/EEC

Electrical energy High-frequency electrosurgical generators, and electrocautery equipment, including their electrodes External pacemakers Defibrillators Electroconvulsive therapy equipment fall under class IIb as per rule 9 of MDD 93/42/EEC..

I would request you to refer the existing thread "European Medical Devices Classification “MEDDEV 2. 4/1 Rev. 9 June 2010

Regards
S. Subramaniam
 
A

asimuh

#3
Thanks for the quick response. I think that is what I was looking for.

Regarding the intended use: The electrodes together with our equipment which has the following intended use:

A device for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway
 
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