How to manage OEM under EU-MDR regulation

Y

yzl1018

Registered
Hello!everybody!
We are a Chinese medical device manufacturer. However, we subcontract part of our manufacturing process to another OEM manufacturer. Our notified body told us that we should treat the OEM as a critical supplier.
But we are not sure what exactly management requirement for OEM under EU-MDR.
Could you please kindly show me the exact management requirement from EU-MDR or other guidance if you know?

I will appreciate it a lot!
Thank you!
 
Raisin picker

Raisin picker

Quite Involved in Discussions
Under MDR, there is no OEM. That was one of the rationales for MDR.
There is one manufacturer, with all responsibilities. Everyone else is supplier. See the "and" in Article 2(30).
 
C

Chrisx

Quite Involved in Discussions
Just a quick search of the MDR, I found Article 10 "General Obligations of manufacturers". Subclause (9) says "The QMS shall address at least the following aspects: (d) resource management, including selection and control of suppliers and subcontractors". You are not going to find the specific details of the supplier controls required in the MDR. The supplier controls need to be defined in the QMS of the legal manufacturer. The extent of control needs to be risk based. There are many other posts on Elsmar about supplier controls, requirements in ISO 13485 and guidance to ISO 13485 for the supplier controls.

Whoever is the legal manufacturer as identified on the label must take responsibility for the supplier controls.
 
Y

yzl1018

Registered
Thank you very much for your kindly reply!
Chrisx said:
Just a quick search of the MDR, I found Article 10 "General Obligations of manufacturers". Subclause (9) says "The QMS shall address at least the following aspects: (d) resource management, including selection and control of suppliers and subcontractors". You are not going to find the specific details of the supplier controls required in the MDR. The supplier controls need to be defined in the QMS of the legal manufacturer. The extent of control needs to be risk based. There are many other posts on Elsmar about supplier controls, requirements in ISO 13485 and guidance to ISO 13485 for the supplier controls.

Whoever is the legal manufacturer as identified on the label must take responsibility for the supplier controls.
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