If your medical devices are exported to Europe, are they being sold in Italy? If so, have they been registered with the Italian Ministry of Health’s online "repertorio" database? If not, starting May 5, they will no longer be able to be sold to National Health Service facilities, nor be entered for public purchasing tenders.
One of the frustrating aspects of the European Medical Devices Directives is that member states are allowed discretion on certain requirements, including registration of higher-risk devices. Italy initially went beyond the directives’ requirements and required registration of Class I devices in addition to those in higher-risk classes.