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Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices?

#1
Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices?
 

Mikilk

Starting to get Involved
#2
The real question is who is the legal manufacturer, who will be marked as such on the device label? if your company is selling the devices under its own name as the "legal manufacturer" than you need to comply with the EU regulations including design and clinical evaluation - can you please explain what is the role of our company?
 
#3
The real question is who is the legal manufacturer, who will be marked as such on the device label? if your company is selling the devices under its own name as the "legal manufacturer" than you need to comply with the EU regulations including design and clinical evaluation - can you please explain what is the role of our company?
Company provides the services that include project management, metrology and outsources production (Injection molding). None of the products currently would be sold as our own or under our brand of even distributed.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Company provides the services that include project management, metrology and outsources production (Injection molding). None of the products currently would be sold as our own or under our brand of even distributed.
Most likely you are not responsible for the CE marking.
 
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