Hi all
Can some one give me links to information regarding EU Medical Devices
directive.
My problem is to define the requirement for the following situation:
A manufacturer is making an add-on device for another company's medical
device and the total equipment is CE approved without involving the
manufacturer. Now the manufacturer want to CE mark this add-on device and
sell it to other companies as a CE approved device still for medical
equipment.
What is the requirements for this manufacturer, they have never been into
CE markin before.
The equipment is used in laboratoriums to move small glases with different
materials for testing in another test device.
best regards,
Kim Jensen
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