Dear all,
We have a current issue concerning own brand labeling and suppliers. We have a company that assembles a class IIa medical device product for us using componets sourced from multiple companies i.e these componets are CE marked as bulk items but not when single packaged. Due us being the registered manufacturer from the point of CE marking we hold all technical files etc on all the items used. The issue is our notified bodies is asking us to have the assembler become the "manufacturer" of the class IIa product. As the assembler is not the manufacturer of the item they quite rightly do not want to comply with this wish. Has anybody else encounterd issues when they have items repacked by an assembler company and ensured all rules can be complied with.? I am sorry if this not enough detail, but i can provide more.
Thank you
Peter
We have a current issue concerning own brand labeling and suppliers. We have a company that assembles a class IIa medical device product for us using componets sourced from multiple companies i.e these componets are CE marked as bulk items but not when single packaged. Due us being the registered manufacturer from the point of CE marking we hold all technical files etc on all the items used. The issue is our notified bodies is asking us to have the assembler become the "manufacturer" of the class IIa product. As the assembler is not the manufacturer of the item they quite rightly do not want to comply with this wish. Has anybody else encounterd issues when they have items repacked by an assembler company and ensured all rules can be complied with.? I am sorry if this not enough detail, but i can provide more.
Thank you
Peter
