Originally Posted by Mithrandir
MikeX, you are saying that all the batteries sold by Medgraphics and Euroenergy, and fitted by lots of us, are a modification when they are identical in form, fit and function?
These parts are a copy and therefore not approved by the OEM. Just because Medgraphics are ISO 9001 registered does not mean they conform to MDR and ISO 13485.

Originally Posted by Mithrandir
The lamps I get from hospital lamps supplies are non OEM, is that a modification too?
Yes, most likely! If you report to the supplier a batch of lamps explode after 20 hours use and have required patients examinations to be repeated how will they report this to all other customers? An OEM would issue a field safety notice for all users.

Originally Posted by Mithrandir
Some bits I can understand the reasoning, but these batteries are all made in the same factories, the OEM sources them from the same sources as the battery suppliers we use, they all have ISO certification and the requisite traceability, it is not as if they are buying off the "grey" market.
They will only have 9001 certificates and not the higher level for medical devices, such as 13485. How do you know they are made in the same factory and to the same specifications? Did the OEM provide you with this information? Again if a fault occurs how will the supplier inform all others of the issue? I doubt they even know who they sold them to!

Originally Posted by Mithrandir
The argument you use sounds like a manufacturer trying to justify monopoly pricing at gouge levels.
It may sound like that but the cost is justified when you understand the legal obligations medical device manufacturers are under. As always, until something happens and it results in a court case will you find out if the cost savings you think you are making are real savings or just “chancing your luck”.