What should be included in the supply contract - Annex 2 list B IVD

[nickie]

We are a small company wishing to distribute an annex 2 list B IVD, manufactured by an ISO 13485 certified company in China. We are working towards ISO13485 certification. I'm looking for some help with what should be included in the supply contract from our point of view regarding things like PMS, vigilance, traceability, managing changes etc. Is specifying these requirements necessary or is it assumed within their CE approval and ISO13485 certification that they would notify us of any quality issues automatically? Presumably they will expect the contract to contain the requirement to notify them if we became aware of any problems with the product? Any help with what should be included and drafting the wording of a contract would be very gratefully received. Thank you.

 

[Ronen E]

Clarification of “distribute” is required.
Under whose name the device is going to be placed on the market (whose name and adress are on the label)?
Does the Chinese manufacturer also have an EC certificate for the device, or just ISO 13485 certification?

 

[nickie]

Thank you for your reply. The product is to be placed on the market in the manufacturer's name; we are merely the distributor. The Chinese company have CE certification for the product. I am aware that the new regulations place additional responsibilities on importers and distributors ( we are both in this case.) I am just unsure since they have all regulatory approval and quality systems in place whether we still need to spell out what we need from them, and if so how to word it.

 

[Ronen E]

We are a small company wishing to distribute an annex 2 list B IVD, manufactured by an ISO 13485 certified company in China. We are working towards ISO13485 certification. I'm looking for some help with what should be included in the supply contract from our point of view regarding things like PMS, vigilance, traceability, managing changes etc. Is specifying these requirements necessary or is it assumed within their CE approval and ISO13485 certification that they would notify us of any quality issues automatically? Presumably they will expect the contract to contain the requirement to notify them if we became aware of any problems with the product? Any help with what should be included and drafting the wording of a contract would be very gratefully received. Thank you.

Thank you for your reply. The product is to be placed on the market in the manufacturer's name; we are merely the distributor. The Chinese company have CE certification for the product. I am aware that the new regulations place additional responsibilities on importers and distributors ( we are both in this case.) I am just unsure since they have all regulatory approval and quality systems in place whether we still need to spell out what we need from them, and if so how to word it.

Thanks for clarifying.

You have asked “what should be included in the supply contract”.
“Should” as in...
- what the “old” (current) IVD directive requires?
- what the new IVDR requires (in effect, will require)?
- what ISO 13485 (2016?) requires?
- what would serve you best commercially / legally (contractual aspect)?
- what common sense would say?

I wouldn’t worry too much about what the Chinese manufacturer will ask to include in the contract; they will take care of their own interests and regulatory obligations. You just have to address the specifics as they come up during negotiations. Since you are merely distributors you don’t have a regulatory responsibility, at least not under the current regime, so you hardly need to cover any bases. Even under ISO 13485 you have quite a limited responsibility because in essence you are simply buying and selling a product unchanged. It probably boils down to receiving inspection to ensure your orders are fulfilled as issued.

 

[nickie]

What prompted my initial enquiry is that we have the opportunity to supply this IVD to a big customer. They require the companies they deal with to be ISO13485 certified, or if they are not the manufacturer to send them the quality agreement between us and the OEM. I need to put something in writing, however brief, and would really appreciate knowing what this should cover. Thanks.

 

[Ronen E]

If you search Elsmar for “supplier quality agreement” (or similar) you may find some useful examples / guidance. For example see this thread.

 

[nickie]

Thank you very much for all your assistance, this looks helpful. Much appreciated.