Third party accessory registration and labelling

[saranjg]

Hi all,


In our class IIb medical device we are using a part from a third party manufacturer. The third party manufacturer is ready to put our label and provide us the device, and ready to share few documents with us, so that we can claim as the legal manufacturers of the part. But as part of confidentiality he will not be able to share design documents which he is ready to share it with auditors or NB during audits.

Again the part which we are getting from them is a modified one from their regular product. so they don't have the part (which they give us) in the market. They are supplying that modified part only to us. Their regular product is CE marked.

In this scenario:

1. can we claim we are the legal manufacturer for this part with few of the documents (which the third party shares) and a agreement with third party? - since we use a modified part , and being the legal manufacturer will we be responsible for the CE marking and DoC for the part? or can we just do incoming inspection and verification with device and label it in our name.?(in this case also when going for registration in other countries how can we handle it)


2. also if we want to register our product in other countries like Malaysia or Singapore or any other countries we may need to provide the dossier which include design details of all parts used in the device( including the part manufactured by third party). But if third party is not sharing those design documents how we can complete the dossier for the registration in such countries? - can we authorize the third party to submit the documents on out behalf.

please help!!!

Thanks in advance..

Saran

 

[yodon]

First, we may need clarification. You use "accessory," "device," and "part" seemingly interchangeably.

From the context, it sounds like this is a fully-functioning device which you purchase from what would be your contract manufacturer. Presuming that's the case, yes, you would be responsible for CE marking (and DoC). You will have acceptance criteria for units delivered. I believe with the MDR, they tightened things down and *I think* the proprietary material would have to be part of your Technical File (I recall discussions about how the new regulation was effectively eliminating Own Brand Labelers). Probably something to discuss with your NB.

If I'm off base in my understanding, please clarify.

 

[saranjg]

Thank you Yodon,

"Part" is a critical component/part of the medical device without which the device will not work.
This critical part is supplied by the third party. And they are not ready to share the technical file with us, but ok to share it with NB or Auditors..
if they are not sharing the TF how will we go about registration of the medical device in which this is a critical part.

please help.

Thank you in advance
Saran

 

[yodon]

Ok, thanks for clarifying. It does make a big difference as I don't think you'd be getting a CE mark for it. You should, then, be treating them as a (critical) supplier (with all the trappings that go with that).

This is probably something you're going to have to take up with your NB. It sounds like the supplier is amenable to sharing confidential information with the NB so it's probably just a matter of figuring out the logistics. You'll want a Quality Agreement that includes a statement about not modifying the part without coordinating with you first.

 

[saranjg]

Thank you Yodon,

we are planning to consider the third party as a critical supplier and have a quality agreement (with all conditions) with them, and get the semi finished product from them(as it is modified from their regular product) as per our specification and use it in our device and do validation and risk assessment.

Hope this will be enough.



Thank you
Saran