Definition of “Manufacturer” under Medical Device Regulation 2012 – A company or person is defined as the legal manufacturer of a device when he takes responsibility for placing it on the market under his own name. His legal responsibility for complying with the Medical Device Regulation 2012 and affixing the product conformity is irrespective of whether he actually performs the design and manufacturing activities himself or the activities are carried out on his behalf by a third party, such as a sub-contractor or supplier.
“Own Brand Labelling” or “Private Label Manufacturing” concept may apply to the above-mentioned “manufacturer” who neither produce nor manufacture, but purchases medical device from an original manufacturer and intends to place that product to the market as a registered device carrying his own brand. They are now legally responsible and obliged to ensure the compliance of this device in accordance with Medical Device Regulation 2012.
The brand owner (“manufacturer”) of the medical devices can appoint DQS as his conformity assessment body to carry out product conformity assessment in accordance with Medical Device Regulation 2012. Upon completion on the assessment, DQS will issue Product Conformity report and certificate in order for the brand owner (“manufacturer”) to register that device in MEdCAST.
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