Virtual Manufacturer v Medical Device File (NB audit)

[TheMightyWife]

Hi all,

I'm new to this forum in terms of posting but I have been watching for years! I do apologise if this subject is discussed elsewhere, I'm sorry I couldn't find it.
We are selling class IIa and class I medical devices that we buy from elsewhere and put our name on it. All products are already CE marked by original manufacturer (manufactured in various countries around the globe).
I'm currently reviewing all files (new to the company, starting with class IIa) and I was wondering if we are able to use original manufacturer's risk assessment documents, as well as ERC, clinical evaluation etc..., without 'rebranding' it with our name?
Is it allowed to include original manufacturer's documents without reformatting?
We would obviously verify it and put it in writing.
Thank you, I'm looking forward to your reply.

 

[paulag]

Hi,

you got an OEM / PLM constellation there - just search the internet to find guidances or checklists on what you can take over from the OEM, and what you have to label with your own company name as a PLM. Eg:
https://www.dqs-med.de/fileadmin/wi...okumente/411_15e_Checklist_OEM_procedures.pdf


https ://www. zlg. de/ index.php?eID=tx_nawsecuredl&u=0&file=fileadmin/downloads/ab/309_1010_B_16.pdf - DEAD LINK REMOVED.

 

[TheMightyWife]

Thank you, I'm still struggling to find anything relevant in UK

 

[paulag]

Thank you, I'm still struggling to find anything relevant in UK

Medical devices: Virtual Manufacturing replaces Own Brand Labelling - GOV.UK

 

[TheMightyWife]

Thank you again
I'm aware of this document (and a lot of others), these still don't answer my question.
I know exactly what should be included in Medical Device File but I'm not sure what documents can be left with OEMs branding rather than ours.
So the question really is if I can include OEMs documents in our file without rebranding them, and if I can, which documents am I allowed to use and which documents have to come form my company?
Any help is appreciated.

 

[DMLqms]

Hi There,

Are you based in the UK?

I'm in exactly the same position but have a reasonably good grasp of what is required. At least until my NB tells me something different!

As a 'Virtual' manufacturer we are now seen as THE MANUFACTURER. This unfortunately means that whilst of course we can refer to our OEM's information, the Risk Management, Clinical Evaluation, Technical File and everything else has to be our own.

We own-brand a huge range of Class I and IIa devices, as well as some on-site actual manufacturing.

The CE certificates of our OEM suppliers are almost irrelevant now - it is all down to us.

Feel free to contact me - I feel your pain!

D

 

[TheMightyWife]

Hello there,
At last someone who can feel my pain
We have very complicated situation here, I'm not comfortable disclosing it here but I don't think we are virtual manufacturers.
We used to manufacture those products ourselves and own the design, when we transferred to subcontractor we let them keep the design as theirs, that I believe changes the situation (even tho they manufacture to our specification).
We also have been told we can't refer to critical suppliers clinical evaluation we had on file, we had to do our own!
That's why I'm asking for a list of documents that we can keep on file with critical manufacturer's name rather than reinventing the wheel and rewriting everything with our name on it...I have two months before the audit to complete 4 files... (*loud cry*)
I'm based in UK.
How can I contact you D?

 

[Remus]

Basicly it depends on your NB.

However on new MDR as far as I know if you have an agreement between your supplier (OEM) you can use your suppliers documents. If you show that from MDR most probably your NB accept your supplier documents.

However, if you have diffrent NB than your supplier, then all documents will be reviewed again...

Also you should update some documents like Risk Management. Where you should add your process risks. (storage, transport... etc.)

 

[RobertvanBoxtel]

Bad news indeed for your situation.
In the end, you are the "legal" manufacturer and needs to demonstrate how your devices comply to Annex I.
If you use technical reports that are relevant, but identify the product differently, it can be accepted if you can adequately explain that they are the same.
For RM/CER documentation, formally the same story. Until you need to change something. Then it becomes troublesome.
If your NB is ok, it might be an option to indicate that you will create your own documentation over the next year (or two) or when you need to update them. Maybe that will spread out the pain over the next year(s).
And, per May 26, 2020, if you cannot comply with MDR article 10, you have a problem anyway, as RM and Clin. Eval systems are required for a manufacturer. A document from someone else is not adequate anymore.

 

[DMLqms]

Hello there,
At last someone who can feel my pain
We have very complicated situation here, I'm not comfortable disclosing it here but I don't think we are virtual manufacturers.
We used to manufacture those products ourselves and own the design, when we transferred to subcontractor we let them keep the design as theirs, that I believe changes the situation (even tho they manufacture to our specification).
We also have been told we can't refer to critical suppliers clinical evaluation we had on file, we had to do our own!
That's why I'm asking for a list of documents that we can keep on file with critical manufacturer's name rather than reinventing the wheel and rewriting everything with our name on it...I have two months before the audit to complete 4 files... (*loud cry*)
I'm based in UK.
How can I contact you D?

Apologies - I've not been on the forum for a while - how is everything going?