CE Mark in Medical Diagnostic Equipment

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Wes Bucey

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#2
Re: CE mark in medical diagnostics equipments

Please note this thread has been moved to a more appropriate Forum where it may get better response.
 
R

Roland Cooke

#3
What is the meaning of CE mark in medical diagnostics equipment?

All medical devices (and any supporting accessories) marketed in Europe are subject to one of the three medical devices directives (as transposed into the relevant laws of each European nation). See here for example.

The CE mark is the manufacturer's legal 'statement' on the product itself, that the device is legally compliant. It may be accompanied by a number, which identifies that a third-party certification has been involved (and which one).
 
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