Updated registration procedures for medical devices in Italy
 
 
As of 1 May 2007, the Italian Ministry of Health (MOH) introduced new mandatory procedures for registering into an on-line electronic databank details of medical devices distributed in Italy that fall under the Active Implantable Medical Devices Directive (90/385/EEC) and Medical Devices Directive (93/42/EEC), except for custom-made devices or devices intended for clinical investigations. A €100 'repertorio' fee was originally payable for each device family registered, because the databank is also intended to provide an on-line catalogue of devices for Italian National Health Service (NHS) hospitals, but a revising decree effective 3 April 2012 deleted this payment requirement.
 
 
There are over 50 questions to be answered for each family of devices, although some are not mandatory. In addition, certain documents must be provided attached to the on-line submission, such as Notified Body certificates and copy labels.
 
 
A new decree took effect from 6 February 2010, revising the amount of mandatory data to be uploaded to the databank and 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 hospitals, ‘commercial’ registration will still be necessary.
 
 
The Ministry of Health introduced the revised decree following pressure from the European Commission and industry associations, because the requirement to register Class I devices and kits/systems in Italy if they had already been notified to another European Competent Authority, was in excess of the requirements included in the Medical Devices Directive 93/42/EEC.
 
 
The new 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 market.
 
 
Italian Customs have advised that the registration numbers for all devices should be included on all shipping documents in order to minimise delays in clearance of medical devices entering the EEA via an Italian port of entry.
 
 
GEMAR is available to provide support in understanding the complex requirements and is able to complete the registration procedure on behalf of clients - contact us for further information or to request a quotation.