Acquired Medical Device Product Line - Documentation Requirements for Device Master Record

[Bruce Wade]

Looking for some guidance...

When a company acquires the manufacturing rights to an established product line, how is the Design History File, and any other similar legacy file, presented?

The company which manufactures the equipment had no part in the design activities, and did not author the original files. How are these presented in subsequent filings and audits?

The company for which I work was formed less than three years ago. The product we manufacture was designed over fifteen years ago and has performed well in its market. The design files, including all schematics and line (CAD) drawings hold the originator's markings.

The device is complex, consisting of multiple parts, assemblies, and subassemblies. Some subassemblies are purchased outside, many are assembled in our manufacturing facility.

I am currently processing an engineering change for the current company. The new CAD drawings wil carry our marks. How do they fin in the Design History File? Do we change and update all the existing, associated CAD drawings?

I am sure there is precedent for the actions which should or might be taken. Even the largest manufacturers of medical devices purchase rights to manufacture lines they did not design. I am just not sure how all should be integrated...

 

[William55401]

I stand by the following . The DHF is an asset that must be maintained by the owner.

Design Responsibilities for Mature Acquired Product Lines

 

[Bruce Wade]

Thank you.

The question is not who maintains the document. On that we agree.

The question is what documents are maintained?

Do we rewrite all the design and development as if we designed and developed the product? Or do we maintain all the previous documents, such as the components of the technical file, CAD drawings, etc. under the previous company name and apply our name only when we modify the components?

My thought is that we begin a new Device Master Record, but use as the base, original technical files from the previous manufacturer, which were current at the point at which the product line was acquired, and move forward from there. And Engineering Change Notices would be under our name and authority, including the new CAD drawings and any modified work instructions.

I am not sure we can "take credit" for the design, but know we are responsible for its maintenance and continued development and modifications.

Your thoughts?

 

[Tidge]

My humble opinion follows: The new owner of the 'product' should maintain enough DHF information to support a complete resubmission to the appropriate regulatory bodies... because they just might require you to do that. DHRs obviously have to be maintained for a sufficient time as specified by regulations. I can't imagine keeping DHR information and not having the accompanying DMR information.

 

[Bruce Wade]

Tidge,

Thank you.

The question is not whether the documents should be maintained. They should and must be maintained.

My question is, should the documents which are maintained remain under the name of the previous manufacturer, or be rewritten under ours.

My concern is that if we rewrite the documents, we had no part in the design or development. The equipment has been performing, very well, in the field for over fifteen years. We have been producing the equipment for just over two.

If an auditor, either regulatory or registrar, asks to see the DMR, which name should appear on the CAD drawings and schematics? The designer's of the current manufacturer? It will require explanation, either way. But i am not sure how to explain our name being on the original documents, given the company was not in existence for over a decade of production.

The Device History Files (DHFs) do carry our name because production is independent of design and DHFs do not carry the manufacturing SOPs or design files.

Am I missing something?

 

[Ed Panek]

I would not alter past DMR or other documents. I would release the new DHF and latest DMR and update DHR documents to reflect ownership. I would then verify regulatory communication using FDA and EU MDD MDR guidance.

for drawings and specs you should sign off anything you did not previously own to demonstrate you reviewed and accepted them. A design review and risk analysis of the changes in ownership and project plan for the transition is also good.

I would also pose a question to your ISO auditor for what to do. They will have experience with this.

 

[Tidge]

I agree with @Ed Panek to not alter (or otherwise update) past records motivated non-technical reasons. If you revise drawings, you will essentially just be expanding the DHF and this will likely be of little value, assuming the original documents are not deficient in some way.

It is natural to assume that a third party may ask a question why a different name appears on prints, but this shouldn't be something to suffer red-faced embarrassment over, assuming that due diligence was done on the acquisition.

Ultimately a drawing is just a design output. In my experience(*1): it is common for a certain class of auditor (typically by personality) to ask a single technical (or quasi-technical, as would be in the case of a specific human name on a drawing) question about a specific design output... when they have some personal curiosity/interest/familiarity, but this is somewhere on the spectrum of sutor, ne ultra crepidam. Less experienced and (IMO) less effective third party auditors can go off on peculiar tangents but there is no general way to prevent such behavior.

(*1) At my current company, we regularly interact with a third-party auditor who ALWAYS asks to see "(software) source code", no matter what the focus of the audit is and how tangential an examination of the source code could be for the audit. The examinations have never been related to a development project/process, nor has the bits of code ever been identified in any sort of corrective action, complaint, or recall... this auditor simply likes to look at code written by other people. I am reminded of a food critic always asking for a different napkin before the meal is served... there is certainly some circumstancence in the past life where the patron needed to do such a thing, but the action has long lost any significance and is borderline obsessive-compulsive behavior.

 

[Philip B]

We have a similar situation. We have just taken over the supply chain of a component which we re-pack, having previously purchased the component from another company who CE marked it themselves. We are now the entity CE marking the component for the first time and therefore take on design responsibility. As a re-packer we have previously excluded design from our QMS but are now going to have to introduce it. We have had no input into the design of the component so I'm also wondering how to incorporate this into our QMS and technical documentation so am very interested in the discussion here.