Wednesday 11 January 2012

If an MEE compliant with the 2nd edition of EN 60601-1 has been shipped before the transition time is over to a distribution centre, does this count as "placed on the market"?

a) If the distribution centre is part of the manufacturer: this does not count as "placing on the market"

b) If the distribution centre is not under the control of the manufacturer, then this counts as "placing on market".

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