EC REP information and CE Mark - Component of a system that is not a medical device

JB0424

Starting to get Involved
I joined a company not long ago. The company markets an old electrosurgical system that includes a cart with its own SKU. The cart is not considered a medical device. The label for the cart lists the EC REP and no CE mark. Is this correct?

Does the EC REP need to be listed if the particular part of the system is not a medical device?

Would the CE mark be needed since it is marketed with a medical device system?

Thanks for any insight!
 

Ronen E

Problem Solver
Moderator
The cart might qualify as an Accessory for a Medical Device (in which case it's treated as a Medical Device).
 

Sullen-gent

Involved In Discussions
I thought carts were class I accessories requiring no 510K in the US and Self declaration of conformity in the EU. That is my previous experience of them. If they have electrical connections and plug into the mains (not sure they all do this) then they would need Test house cert. for electrical safety (US).
 
Top Bottom