QR Code on Medical Device Packaging and Notification to Notified Body

[ciccina]

Dear All,
I have a question related to the reporting of MD changes to notified body. The manufacturer wants to introduce a QR code to the packaging of the medical device. The QR code refers to a video in which the MD is presented and the mode of use is explained. This information reported in the video is in compliance with the content of the labels already notified. In this case, do you think it’s necessary to notify the change to the notified body or the change can be considered not substantial?

Thank you in advance!

 

[chris1price]

It probably depends on the Notified Body and their definition of "substantial". Also check out NB-Med 2.5.2 -2. I suggest carefully checking your agreement with them and whether they have any guidance documents on the subject. If in doubt contact them.