Mediqol

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!