Sterling medical Registration
For Medical Device and in vitro diagnostic medical devices, the label or outer packaging or instructions for use shall contain the name and the address of the authorized representative where the manufacturer does not have a registered place of business in the Community.
Where a manufacturer who places a device on the market under his own name does not have a registered place of business in EU, he shall designate An Authorized Representative.
An "Authorized Representative" under the Medical Devices Directives, means:
Any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by
authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this directive.
The appointment of an authorized representative does not change the responsibilities of the manufacturer.
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