Electrical code Compliance - Classification of Medical Devices (Risk Class)

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Classification of Medical Devices (Risk Class)

doneirik

2007-05-16, 9:25 am

Dear Group,

I have a question as to how to interpret the European MDD concerning
the classification of Medical Devices.

If a diagnostic device being both active and surgically invasive,
which rule apply?

My advisor says as long as the device is active, the rules concerning
surgically invasive devices do not apply even though the device would
have been in a higher risk class if the rules concerning surgically
invasive devises were considered.
Is this the current practice?

regards
doneirik

usrdab_No_Spamola_@optonline.net

2007-05-19, 1:25 pm

From what you describe, doesn't Directive 90/385/EEC (Active
Invasive Devices) apply?

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