Tuesday, 6 December 2011

If I am not selling my IEC 60601 2nd edition complying product in EU then can I retain CE mark on my device after Jun 2012 for selling in rest of the World?

To sell the product to the Rest of the World, you must comply with the local laws and regulations of that particular State. If that particular State needs also a 3rd edition testing compliance, then you must comply with the 3rd edition. If they are happy to accept the 2nd edition testing only, you may be able to sell them, but the CE mark is for Europe only, and in Europe you must comply with the 3rd edition anyway. Therefore, after June 2012 if you want to retain your CE mark you must demonstrate compliance against the 60601-1 3rd Edition standard.

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