In 2007, the Italian Ministry of Health (MOH) introduced mandatory procedures for registering medical devices on the Italian market into an on-line electronic databank, and it is expected that this local requirement for national registration will continue, even when the new Eudamed database is fully operational under the 2017 medical device regulations, because the databank also serves as an on-line catalogue of devices available for purchase by Italian National Health Service (NHS) healthcare facilities.
The registratin process requires over 50 questions to be answered for each family of devices, although some are not mandatory. In addition, certain documents must be attached to the on-line submission, such as Notified Body certificates and copy labels and instructions for use.
Initially, all classes of device needed to be registered, but a new decree took effect in 2010, removing the requirement for Class I devices and kits/systems to be registered, unless the manufacturer or authorised representative is located in Italy. However, although there is no longer a ‘regulatory’ requirement for Class I devices and kits/systems to be registered, if companies want to sell their devices to Italian NHS healthcare facilities, ‘commercial’ registration is still necessary. The decree explains that entry of the details of Class I devices and kits/systems is now ‘voluntary’, but it is clear that unless registered, the devices will be ‘invisible’ to NHS purchasers, and therefore excluded from the Italian public healthcare market. In vitro diagnostic devices (IVDs) were included in the registration requirement in 2013.
Italian Customs has advised that the registration numbers for devices should be included on all shipping documents in order to minimise any delays in clearance of medical devices entering the EEA via an Italian port of entry.
Donawa Lifescience Consulting is available to provide support in understanding these complex requirements, and is able to complete the registration procedure on behalf of clients - contact us for further information or to request a quotation.