T
temujin
Dear Cove,
When writing the Declaration of Conformity for electromedical equipment is it enough to state conformance with the Medical Directive 93/42/EEC? (or the IVDD respectively)?
Do I need to explicitly state conformance with the directive for e.g. electromagnetic compatibility (2004/108/EC), or is this already implicit in the confomance to MDD?
I know I have read something about this before, however, as I am now in the process of issuing the DoC, I was hoping for a quick answer here...
best regards and thanks
t.
When writing the Declaration of Conformity for electromedical equipment is it enough to state conformance with the Medical Directive 93/42/EEC? (or the IVDD respectively)?
Do I need to explicitly state conformance with the directive for e.g. electromagnetic compatibility (2004/108/EC), or is this already implicit in the confomance to MDD?
I know I have read something about this before, however, as I am now in the process of issuing the DoC, I was hoping for a quick answer here...
best regards and thanks
t.