A new Italian Decree , dated 23 December 2013, was published in G.U. n.103 of 06 May 2014, describing a new process for the registration of in vitro diagnostic devices in Italy.
With this new decree, all IVDs that are currently required to be registered in Italy (devices included in Annex II A and II B and devices for self-testing, all IVDs manufactured by an Italian manufacturer and/or by a non-European manufacturer but with an Italian AR) from 5 June 2014 have to be registered only through the same on-line databank that has been used for the registration of other medical devices since 2007.
The new decree also explains that if any manufacturers of any type of IVD want to sell their devices to Italian NHS healthcare facilities or to respond to public tenders, they must also be included into the 'Repertorio'.
IVD devices already notified to the Ministry via the 'old' system are still valid and do not need to be re-registered with the databank. However, if such devices need to be amended and/or if the devices need to be included into the Repertorio for public purchasing reasons, then re-registration into the databank will be necessary.
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