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!
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!