Posts Tagged ‘Repertorio’
European Commission loses patience with additional Italian registration requirements
We’ve reported previously on the Italian Health Ministry’s controversial Repertorio system which requires non Itailan device manufacturers to register their products on a database. Well the EC has now decided to take infringement proceedings against Italy regarding the additional requirements on the basis that they go beyond EU law and put non Italian device manufacturers at a disadvantage as they are difficult to comply with. The deadline for device manufacturers to comply with the additional requirements had already been put back to December 2008 but perhaps now they’ll end up being scrapped?
Italian Repertorio deadline extended
We’ve been working with a number of device manufacturers recently regarding the new requirements for device registration in Italy which involves entering product information on a database and validating this information using an electronic signature (Smartcard).
As with any new system it has its teething problems and we’ve just heard that the deadline for registration and coding of devices in the system , “the Repertorio” has been extended once again to 31 December 2009. This extension enables all medical devices to still be sold despite not having the code required by the Italian legislation that was first introduced in 2007.
This provides manufacturers with a little breathing space but they still need to get their products on the register by the end of the year.
For assistance with the registration of medical devices in Italy please feel free to contact us!
