Medical Device (MedDev) Vigilance Guidelines for Importers into the UE

[ODISSEAS]

Hi friends,

once checked contents of april 07 edition of vigilance MedDev guidelines, I cannot find reference to role of importers into UE.

Briefly, if we act just as merely importers, not AR, obviously we must process complaints related with incidents reported by customer, communicating it to mfct. Also to competent authority?. Mfctr and AR is better?. For that cases, is suitable to use same wording (Field Safety Notice, v.g.) for our communications to authority and mafct?.

Thanks for your suggestions.