We are General IVD medical device company following EU Directive 98/79/EC on In-Vitro Diagnostic Devices. Out notified body is trying to get us EN ISO 13485 certificate, which I am little skeptical about. I think we need ISO 13485:2016 not EN version since we sell all over the world not only in Europe. Also, our product are General IVD-Self Certified CE mark not 4 digit CE marked from Notified Body. Can someone please clarify this for me and let me know if we need ISO 13485 or EN ISO 13485? I know there is only one difference in Annex ZC with EN version but I don't want to get a wrong certificate for the company Really appreciate your help.