Obelis European Authorized Representative Center"CE Marking Consultants with a Reputation for Excellence"
Manufacturers incorporating electric components to medical devices may find a dilemma when addressing the conformity to the 3rd edition of the IEC 60601-1, in reference to medical devices already on the distribution channel or such devices about to be shipped out of the factory. What does the standard mean? What do you have to do as manufacturers of medical devices and systems to still be able to distribute your products on the European Market come June 2012 (when the 3rd edition of IEC 60601-1 shall be fully applicable).
Read all you need to know about this in our publication.
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