S
Hi all,
we(as a virtual manufacturer) want to add few OEM products in our product list and sell those products in our name and also put CE marking.
The OEM already have CE. Can we put "manufactured by" our address and use their CE marking.
or
shall we get the technical file from OEM(they are ready to share the technical file accept few documents which they will share with EU representative directly)and go on registering the product with our EU representative(which we have for our own products) and put CE and our address as "manufactured by"..on the product.
Please give suggestions if the above process can be done.
and also what about ISO 13485, as a virtual manufacturers can we add these products in our scope? or have to do a audit at OEMs place?
Thank you in advance
Sara
we(as a virtual manufacturer) want to add few OEM products in our product list and sell those products in our name and also put CE marking.
The OEM already have CE. Can we put "manufactured by" our address and use their CE marking.
or
shall we get the technical file from OEM(they are ready to share the technical file accept few documents which they will share with EU representative directly)and go on registering the product with our EU representative(which we have for our own products) and put CE and our address as "manufactured by"..on the product.
Please give suggestions if the above process can be done.
and also what about ISO 13485, as a virtual manufacturers can we add these products in our scope? or have to do a audit at OEMs place?
Thank you in advance
Sara