Virtual Manufacturer / OBL ISO Requirements

B

BenAMS

#1
Hello, my company is an Own Brand Label (OBL) medical device manufacturer and are in the process of implementing a QMS and planning to market within the EU.
I would like to know if anyone has any advice/guidance on how to manage our sourced Original Equipment Manufacturers (OEM) per the new MDRs/ISO.
Any help/advice would be greatly appreciated.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello Ben, welcome to the Cove.

As far as I know there are no special provisions for OBL in the new MDR. Your org will be the responsible manufacturer, and you should manage your OEM as a supplier (obviously, wherever it matters it should be considered critical or the likes).

If you need close assistance in preparing for the new MDR please send me a PM.

Cheers,
Ronen.
 

pkost

Trusted Information Resource
#3
As Ronen said, there are no specific provisions in the MDR for OBL/OEM. In fact there were never any in the MDD.

As a word of caution, in the past, OBL used to be a quick route to market, you could request some documents from the OEM, sign a Technical agreement, promise to collect and report complaints and pretty much forget about it.

Over the last 5 years of so, this lax attitude has progressively tightened. NB's started requesting more documentation; you must now stay on top of the documentation and maintain it (don't let it gather dust).

In the last year or so, I've frequently heard people say that OBL/virtual manufacture is dead. While I don't necessarily agree, it is certainly the case that the expectation is now that you are fully a manufacturer and must act as one.


In this vain, with regards to managing your OEM; you should manage them as you would any other supplier, however that may be. I would strongly recommend auditing them. You must be on top of document control, don't let your documentation gather dust, make sure they inform you of changes. It is a delicate relationship as they view themselves as the owner of the product/design, however while this may be true and accepted in the past, the regulatory authorities now view you as responsible and therefore in control.
 
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