Retrofitting Medical Devices - Who is the Manufacturer after the Retrofit?

fialor

Involved In Discussions
#1
Folks this is my first post on here so please bear with me.

With EU medical devices regulations, where person A retrofits person B's product with his, person A then becomes the manufacturer for the purposes of the law and ensuring that the now new product is compliant with with applicable regulation.
Is this correct or have I mis-understood it?

Thanks
Fialor
 
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fialor

Involved In Discussions
#3
Thanks Gert.
Retrofit or retrofitting is an instance of modernizing or expanding with new or modified parts, devices, systems, or equipment. It is usually where a new function or part of added to an old device to make it more "start of teh art" or more current in technology.
Thanks
Diana
 
G

Gert Sorensen

#4
From the MDD:

(f) ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.
This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

The emphasis in bold is mine. I believe that should answer your question.
:bigwave:
 

fialor

Involved In Discussions
#5
Thanks Gert, that is very clear but unfortunately does not answer my question.
The retrofit is not done on product before they are placed on the market but rather afterwards.
It is sometimes argued that this change/retrofit creates a new product hence my question.
Article 12 of the MDD 93/42/EEC states only a declaration is required where all the components are CE marked. However it appears to refer to new products only.

My question is how does it affect old, exixting products - already on the market and in use.
Thanks
 
S

SteveK

#6
This might not be the best example but here goes. A number of suppliers market portable suction pumps (aspirators). These can be supplied fitted with their particular make of receiver jar for collecting bodily fluids. Both are medical devices in their own right (i.e. CE marked) and may have been used together for years. The supplier of the suction pump then supplies a kit (to a customer) so that a receiver jar from a different/new suppler can now be fitted (i.e. retrofitted). Then there is no issue here with regards the regulations in this case - as it currently happens. However, if the change is more drastic this may not be the case, especially if it affects overall function. I know there maybe an intellectual property issue but can you be more specific?

Steve
 

fialor

Involved In Discussions
#7
Thanks SteveK.
Yes - I cannot really go into details, but I can elaborate as follows:
It is xray equipment meant for both diagniosis and therapy. The equipment in question uses old technology but an be retrofit (upgraded) with new parts which have new technology. The new parts are nott from the original manufacturer. Both products are individually CE marked. Meaning that had they been new, under article 12, they would still be compliant and the new parts manufacturer would be olay with just a DoC for compliance.

This is my dilemma - does the old product also fall under article 12 and therefore compliant?

I am trully thankful for the feedback.

Regards
Fialor
 
S

SteveK

#8
As a first off the device manufacturer (who put it on the market) I think should notify the NB under NB-MED/2.5.2/Rec2 "Reporting of design changes and changes of the quality system" because it it would be seen as a "substantial change" to the original. Technical file etc to be updated I would have thought. Other than that, I am out of my comfort zone in commenting any further, especially as you should obviously keep close details under wraps!

Steve
 

somashekar

Staff member
Super Moderator
#9
It is sometimes argued that this change/retrofit creates a new product hence my question.
Article 12 of the MDD 93/42/EEC states only a declaration is required where all the components are CE marked. However it appears to refer to new products only.

My question is how does it affect old, exixting products - already on the market and in use.
You are creating a new product from the regulatory angle, and you are the manufacturer.

This is my dilemma - does the old product also fall under article 12 and therefore compliant?
Under no circumstance will the old product manufacturer stand by you to prove any compliance. Once you retrofit, forget him and own the complete device.
 
Last edited:
M

MIREGMGR

#10
Stop using the regulatorily undefined term "retrofit" and use "refurbish" instead, and your stance becomes clear. A refurbisher takes on full responsibility for the refurbished device, not just for the parts used and work done, irrespective of whether it was brand new or ancient when refurbished.

The rule is essentially identical under US FDA.
 
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