Medical device file for components such as adhesives, gaskets, films, etc.

[cubix rube]

We are a contract manufacturer of die cut components, such as adhesives, gaskets, films, etc., that are used by our customers as components in their finished devices. We don't design or make any finished devices. We are transitioning from 13485:2003 to 2016, and our audit is in October.

Currently, our DMR includes things like drawings, quotations (from us to our customer, and our vendors to us, etc.), change orders, etc., but they're all related to the little component we're making, not an actual medical device.

We have some customers for whom we make several different parts, and they also make several finished devices. We have no idea how many, or which of our components goes into which of their devices, or how their devices are used.

Do we simply need to add a checklist (demonstrating conformity to this requirement), showing that we have at least just the things that apply? For instance, we would have a design record, but not necessarily instructions for use, since our customer designed this component, and knows how to use it in the building of their device.

 

[Marcelo]

This is one of the (several) errors in ISO 13485 that remained after we expanded the scope (and would not find all instances that needed change before and advanced time in the development). The Medical device file should be required only for manufacturers.

And so it could be NA for others. However, the standard does not allow for NAs outside clauses, 6, 7 and 8.

 

[Roland chung]

And so it could be NA for others. However, the standard does not allow for NAs outside clauses, 6, 7 and 8.

Does it mean that contract manufacturers have to establish the Medical Device File?

 

[cubix rube]

Interesting. That leads to another question. In 4.1.1, where we have to document our role, I would assume, then, that we are NOT a manufacturer? Would that make us an Authorized Representative, since we are performing a part of the overall manufacturing process on behalf of, or at the behest of the manufacturer? I saw another thread where something along these lines was put out there.

 

[Marcelo]

Does it mean that contract manufacturers have to establish the Medical Device File?

It means there's not way for anyone to deem the medical device file 4.2.3 NA.

 

[Marcelo]

Interesting. That leads to another question. In 4.1.1, where we have to document our role, I would assume, then, that we are NOT a manufacturer? Would that make us an Authorized Representative, since we are performing a part of the overall manufacturing process on behalf of, or at the behest of the manufacturer? I saw another thread where something along these lines was put out there.

The manufacturer in 4.1.1 is the manufacturer of the medical device.

On the other questions, it really depends on what you do. If the manufacturer buys your finished products that fulfills their requirements, you would be a supplier (and requirements on 7.4 would apply).

If you perform part of what the manufacturer should do following ISO 13485 and regulatory requirements, you are a third party that is working as you were the manufacturer, in their name and responsibility (including having a quality agreement which details, between other things, who does what to fulfill the regulatory requirements). In this case, 4.1.5 would apply.

 

[cubix rube]

So it sounds like you're saying that due to a "mistake", this requirement to establish the Medical Device File applies to everyone, but it should only apply to manufacturers, which it sounds like we are not. But then, you say that because it's not in 6, 7, or 8, we can't make it NA. So then, what are we to do? We can't meet all of those requirements for this file for reasons previously stated, yet we can't make it NA.

Also, as I understand it, we can only choose from among the 4 roles listed in the standard, i.e. manufacturer, authorized representative, importer or distributor. In one reply, you said we sound like a "supplier", so 7.4 would apply. Supplier isn't in the list of 4 roles, and if I was a supplier, wouldn't 7.4 apply to MY customer?

I appreciate your knowledge, but your replies, at least for me, raise more questions than they answer. For whatever reason, I'm just not getting it. My apologies. Thank you.

 

[Marcelo]

So it sounds like you're saying that due to a "mistake", this requirement to establish the Medical Device File applies to everyone, but it should only apply to manufacturers, which it sounds like we are not. But then, you say that because it's not in 6, 7, or 8, we can't make it NA. So then, what are we to do? We can't meet all of those requirements for this file for reasons previously stated, yet we can't make it NA.

Unfortunately, I don't see any solution in the current text for that. The only possible "solution" is to create a "bogus" medical device file with the information you have. If you are in a certified environment, hope that the evaluator agree with that.

Also, as I understand it, we can only choose from among the 4 roles listed in the standard, i.e. manufacturer, authorized representative, importer or distributor. In one reply, you said we sound like a "supplier", so 7.4 would apply. Supplier isn't in the list of 4 roles, and if I was a supplier, wouldn't 7.4 apply to MY customer?

You can "choose" between any roles the applicable or applicable regulation permits. In Brazil, for example, there's 7 or 8 different roles, which are not mentioned by ISO 13485. Please note that ISO 13485 is more like a "placeholder"standard, in which you either use what the regulations requires or, if not available, you then use default ISO 13485.

Regarding 7.4, sorry, I may have made things more confusing, as I was addressing a supplier in the view of the application of ISO 13485 by a manufacturer of the medical device, not the supplier itself.

What I meant to say is that, if a manufacturer is applying ISO 13485, and buys a from you, your relationship from the standpoint of their ISO 13485 application would be under 7.4 (and you would be considered a supplier). If a third party, it would be 4.1.5 (and you would be a contract manufacturer).

So, "supplier"or "contract manufacturer" would be the role (if the applicable regulations, which are applicable to the manufacturer generally, says so).

Also, in your application of ISO 13485, 7.4 would apply between you and your suppliers, yes.

I appreciate your knowledge, but your replies, at least for me, raise more questions than they answer. For whatever reason, I'm just not getting it. My apologies. Thank you.

Well, unfortunately, there's no real answer, that's what I'm trying to point out. Although the standard now can be applied to everyone involved in the medical device lifecycle, from material suppliers to end-of-life disassemblers, for some, the current text will have some problems and won't enable a clear application.

 

[BhupinderSinghPawa]

Interesting. That leads to another question. In 4.1.1, where we have to document our role, I would assume, then, that we are NOT a manufacturer?

What is the scope mentioned in your current ISO 13485 certificate and the Exclusions & Non Applicability mentioned in Quality Manual?

As the scope, i presume, is to make custom manufacture of parts and assemblies used in medical devices (and not medical devices themselves).

You could there on interpret the requirements of 4.2 to state that Device Master File is responsibility of the 'manufacturer'. To the extent applicable, you maintain the DMR (product, process, QA specifications ...) for the parts and assemblies, as 'contract manufacturer'.

These also should be stated in respective Quality Agreements with your clients.

The clauses 4, 5, 6, 7 and 8 will apply. Clause 8.2.3 Regulatory Authority Reporting; similarly at the Medical Device Level is 'manufacturer' responsibility.

Would that make us an Authorized Representative, since we are performing a part of the overall manufacturing process on behalf of, or at the behest of the manufacturer? I saw another thread where something along these lines was put out there.

You are certainly not Authorized Representative. In EU, AR is in country representative for manufacturers based out of EU, and liaisons to NCA.

 

[QE1993]

I have a procedure stating that our Methods of Manufacturing, which include or reference the print, instructions for manufacturing, and associated procedures is our DMR, but as contract manufacturer's of medical components, we do not legally know the intended use/purpose nor do we have any labeling requirements.

Our Auditor was ok with that.