Hi
I would appreciate some help with the following scenario.
We (UK Company B) purchase Self test IVD's for home use (pregnancy tests) from OEM (China Company A) as OBL with our name.
We have ISO 13485 and Notified body approval as an OBL.
We have a request from UK Company C (UK retailer) to provide them the same product with company C trademark on front of pack and company C pack design with Company C noted as distributor and company B as manufacturer.
Our notified body has said this can't be done. Notified body and all the regulations seem to say that Company C becomes the manufacturer and has to fulfill all the required manufacturers quality system requirements as well as apply to their own notified body for approval of the products.
Every UK retailer as well as many European retailers has their own brand of pregnancy test branded as their product but with distributed by instead of themselves as the manufacturer. It has been this way for many years.
How is this achieved or has it all changed with the adoption of the 2013 & 2016 rules?
I would appreciate some help with the following scenario.
We (UK Company B) purchase Self test IVD's for home use (pregnancy tests) from OEM (China Company A) as OBL with our name.
We have ISO 13485 and Notified body approval as an OBL.
We have a request from UK Company C (UK retailer) to provide them the same product with company C trademark on front of pack and company C pack design with Company C noted as distributor and company B as manufacturer.
Our notified body has said this can't be done. Notified body and all the regulations seem to say that Company C becomes the manufacturer and has to fulfill all the required manufacturers quality system requirements as well as apply to their own notified body for approval of the products.
Every UK retailer as well as many European retailers has their own brand of pregnancy test branded as their product but with distributed by instead of themselves as the manufacturer. It has been this way for many years.
How is this achieved or has it all changed with the adoption of the 2013 & 2016 rules?