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.
However, a new decree taking full effect this week has added confusion to an already obscure process. In response to pressure from the European Commission and industry associations, registration of Class I devices is no longer necessary for "regulatory" purposes under the new decree. Unfortunately, the online database is also used as a catalog of available devices by purchasers within the NHS. The new decree makes it clear that "voluntary" registration of Class I devices is possible. So any manufacturer wishing to sell Class I devices to public healthcare facilities in Italy will still need to register its Class I devices, on a purely "commercial" basis, if the devices concerned are not to be effectively excluded from the market.
For assistance in checking the current registration status of your devices, or for making new registrations, drop me an email or visit our website for additional information.
Roger Gray is vice president of quality and regulatory for Donawa Lifescience Consulting. Based in the U.K., Roger has worked for more than 30 years in the medical device industry, specializing in European and U.S. regulatory and quality management requirements, in particular for electro-medical, minimally invasive and associated devices.
