Hi Elsmar Community!
I am in the process of EU MDR compliance for Class I devices and there is a question on label updates per EU MDR Annex I Chapter 3. Per the new requirement we need an indication that the device is a medical device and we have chosen to go with the industry standard label symbol "MD". However, what I need help understanding is whether this label needs to be applied to all CE-marked (Class I) devices that have already been built and are currently in the inventory. To provide more details, these products are final finished devices (non-sterile) that have been packaged and labeled already. Will these require re-labeling?
I am in the process of EU MDR compliance for Class I devices and there is a question on label updates per EU MDR Annex I Chapter 3. Per the new requirement we need an indication that the device is a medical device and we have chosen to go with the industry standard label symbol "MD". However, what I need help understanding is whether this label needs to be applied to all CE-marked (Class I) devices that have already been built and are currently in the inventory. To provide more details, these products are final finished devices (non-sterile) that have been packaged and labeled already. Will these require re-labeling?