We just had an unannounced MDD audit yesterday. The auditor reviewed the last Management Review, which mentioned that ISO 13485:2016 had been published. He commented that we should have called out EN ISO 13485:2016. Can someone tell me what the differences are between the two versions? I know that I was required to write a commentary (for the same notified body) on the differences between the two earlier versions. I'd hate for this small company to have to purchase yet another copy of 13485 if there are no differences. But I can't seem to find anything on the EN version, except for purchasing information. Can anyone comment?