Medical Device Traceability

Morlock

Involved In Discussions
#1
Hello all.

As a contract manufacturer of an "implantable finished medical devices" that are returned in bulk to the client for sterilization, final packaging, labeling, distribution, sale, etc., to what extent to we have to implement ISO 13485:2016 Section 7.5.9.2? Is the client the only "distributor" that we have have traceability requirements for, or do we need to require it for all of THEIR distributors, as well?

Additionally, regarding FDA 21 CFR 821, is there a way to predict if the FDA will issue an order for serialization?

Thanks much.
 
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Morlock

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#3
Thanks, that helps, however doesn't fully answer my question. The device we contract manufacture is not on the list of "Medical Devices Requiring Tracking", however it does fall into the "Section 519(e) states the Agency may require tracking for a class II or class III devices (A) the failure of which would be reasonably likely to have serious adverse health consequences; or (B) which is i. intended to be implanted in the human body for more than one year; or ii. is a life sustaining or life supporting device used outside a device user facility."

From what I've gathered, it's not currently required, but it could be in the future. Is there a way to predict? Implementing a tracking system seems to be a large investment of time and money, so we'd rather not do it unless necessary.

Also, if we contract manufacture the devices, and bulk ship them to the client for distribution, do we just need to ensure that they have a competent tracking system in place, or does that system need to be transferred to us to be under our own, in-house control?

Lastly, if we do need to implement a tracking system, does anybody have any recommendations for systems that work for them? If the device is individually packaged, can the package simply be labeled, or does the device itself need to be marked?

Thanks all!
 

Mark Meer

Trusted Information Resource
#4
...As a contract manufacturer of an "implantable finished medical devices" that are returned in bulk to the client for sterilization, final packaging, labeling, distribution, sale, etc., to what extent to we have to implement ISO 13485:2016 Section 7.5.9.2? Is the client the only "distributor" that we have have traceability requirements for, or do we need to require it for all of THEIR distributors, as well?...
Correct me if I'm wrong, but from what I understand, you do NOT do sterilization, final packaging, labeling, or distribution? Does the client market the device under their own name? Are they the ones assigning UDI as part of their labeling? If so, I don't think that you have responsibility to trace to end-users.

Also, I could be wrong, but if sterilization is a requirement, then wouldn't what you supply not actually be considered a "finished device"? If this is the case then you wouldn't technically be a "contact manufacturer", no? ...not certain, just throwing out ideas for discussion. Interesting discussion...
 

Edward Reesor

Trusted Information Resource
#5
We are one step "downstream" in the supply chain from you and although we are closer to the end user, I only get direct sales tracings from one or two distributors (none in Canada). All the others either require payment for the information or state that they do not release it. Having said that, we ensure that they are licensed to sell the equipment and therefore are knowledgeable in their roles and responsibilities (and expect that the national licensing bodies perform their role, not us).

This didn't sit well with one MDSAP auditor who wrote a NC for not having a signed agreement or acknowledgement from them. We have agreements with the larger companies but also sell to smaller, independent players for some medical devices we offer. If you have a contract with this customer, then there should be a section that acknowledges their roles and responsibilities for traceability.
 

Morlock

Involved In Discussions
#6
You are correct, Mark, we do not perform any of those services to the device. We get all the components in, we assemble and test, then send them in bulk to the client. Yes, the client markets it under their name, and assigns UDI. We are just a sub-contract assembly service provider. However, the catch is, per FDA definitions (21 CFR 820.3, "Finished Device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized." So, since the device is "capable of functioning" as it comes off of our assembly line, it is considered a "finished device", and from what I have gathered, that makes us the "Manufacturer", with a number of responsibilities that come with that title, including traceability. Perhaps there's an out, but from scouring 12 CFR and ISO 13485:2016, my interpretation thus far is that it is indeed a finished device, and that we we are indeed the manufacturer.

Edward, thank you. Reviewing contract and quality agreements is on my list of things to do for this project yet. Is this something where I can just pass on this responsibility to the client via a clause in the quality agreement, and as long as we have traceability to them we're good? On face, that seems a bit fishy, but I'm fairly new to this gig, so if it's standard and accepted practice, that would be good news.

Thanks all.
 

Edward Reesor

Trusted Information Resource
#7
Our philosophy for the distributor was, "You're licensed to sell, so its the jurisdiction of Health Canada/FDA to ensure your compliance, not ours." That wasn't deemed good enough for this one auditor (although the lead auditor questioned her actions but didn't want to argue). We can't force the distributors to release this information but can record their refusal to our requests and would argue if a NC against not having the tracing information was filed. Her NC was to have an agreement in place specifically stating their responsibilities, but our approach was to send off a letter to be signed with a simple statement that they are aware and will follow the regulations (we weren't going to have a formal distribution agreement for a small player who wants to buy 10 units for a training course).

The other option that was rejected was to have every invoice carry a statement similar to, "Receipt of this product binds the receiver to follow all legislation and regulations associated with the sale in their jurisdiction" (or something like that). That was deemed to heavy handed.
 
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