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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.
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.