2023.02.24

National Authorities improve their vigilance systems, but that is far from harmonization.

It makes the system even more complicated if every authority creates their own reporting system. Such changes don’t make it easier to keep EU and non-EU manufacturers selling their devices in Europe. 

See the new e-service for vigilance submissions for Sweden. This website should be used for submissions until EUDAMED is mandatory for vigilance. No registration is required.