Responsibilities of Importers / Distributors - MDR

#1
Would you be so kind and describe how do you perform or plan to perform responsibilities of importers / distributors requested by MDR:
- making sure that the devices bear the CE marking
- labelling is in accordance with the Regulation
- have assigned a UDI where applicable
- verify that devices are registered in EUDAMED
- inform manufacturers and their authorized representatives in the event of complaints
- keep a register of complaints, non-conforming devices, recalls and withdrawals
- escalate non-compliance to authorities if they suspect that a device has been falsified or that there is a serious risk to health.
- cooperate with authorities and make available all the documentation and information they have at their disposal

Please correct me if I missed some of the responsibilities.

Please share how to implement vigilance (to what degree) for MD?

Thank you.
 
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shimonv

Trusted Information Resource
#3
You will need to develop internal procedures or policies to address each of the points you mentioned.
Also, some training would be useful..
It would be good if one of your supplier (MD manufacturer) can provide you with an example of vigilance procedure to work with.
 

twanmul

Involved In Discussions
#4
I'd also expect contracts with your suppliers to be updated/amended to reflect the updated responsibilities. This makes it clear that everyone is aware of what they should do and need to provide in order for you to execute your responsibilities fully.
 
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