One Medical Device - Two Legal Manufacturers

Aphel

Involved In Discussions
#1
Hello!

Imagine the situation, there is a medical advice (class 3) with EU market approval and a responsible legal manufacturer...

Is it possible to install a second legal manufaturer, which has its own quality system, who is also responsible for the same medical device in parallel?

Sorry for this strange question... but thanks alot for your comments in advance!

BR
Aphel
 
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pkost

Trusted Information Resource
#3
slightly longer answer:

This is known as own brand labelling.

One company acts as the designer/manufacturer. The second develops their own technical file which refers back to the first company to demonstrate conformity against the requirements i.e. on the ER checklist "Our product complies with this essential requirements because it is an existing medical device bearing a CE mark...Evidence DoC and EC certificate"

http://www.team-nb.org/documents/20...formity_Assessment_of_Own_Brand_Labelling.pdf
 
K

kbryde

#4
I understand why one would say "Yes", but in the regulatory sense of the term, I would say "No" - there can only be one responsible party for a marketed device. If you go with the OBL, as the original legal manufacturer, you would be "reduced" to contract manufacturer, and you would have to accept that the now legal manufacturer gets access to your technical documentation. Previously, in my own experience, Notified Bodies and authorities have not gone after this that aggressively, but recently that has shifted and you could be asked as an OBL to present all technical documentation for a device with a contract manufacturer, it is no longer acceptable to state that you have a Tech File with reference to the original and that you audit the contract manufacturer on a regular basis. This could compromise any IP the original manufacturer may have. There are many considerations on both sides of this arrangement to be made before jumping into contract manufacturing of a device for which you are already the legal manufacturer, in my opinion!
 

pkost

Trusted Information Resource
#5
While I agree that the regulatory environment is changing and there are increasing demands on manufacturers, the own brand labelling method is, at least in the short to medium term here to stay. To suddenly close this route to market down would seriously damage the industry in Europe, would result in price increases and reduced competition and customer choice - not something the EU wants to do!

The documentation required is an interesting discussion. It is my belief that as an own brand labeller you have your own documentation, your evidence of conformity is the DoC and EC certificate of the OEM, there is no need to actually have the OEMs documentation.

The contract is in place to give CAs/NBs access to the information if neccessary, but to primarily exchange vigilance information and have change control (you still have an obligation as OBL to report a change has occured to your OEM even if you don't have direct visibility of what it is)
 
K

kbryde

#6
I hope you are right in the assumption that the EU will not go through with this - at my company we act as both Legal Manufacturer and contract manufacturer and have been able to create contracts as a work-around for handing over tech files etc to our OBL customers, but have been warned by both our NB and the regulatory agency, that this wil most likely no longer be acceptable with the implementation of the new MDD. It will be undermining the industry and jeopardizing IPs for many manufacturers, so let?s hope that the EU realises this before it is too late!
 
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