Update on Medical Device Registration in Italy

Changes to the registration requirements for medical devices in Italy have been issued, namely that registration no longer is required for Class I devices for which European authorized representation is established outside of Italy. But, alas, as is the case with most happy and too-good-to-be-true tidings in the regulatory world, there is often a slight catch.

As you may be aware, Italy's Decreto 20 Febbraio 2007 (Decree of Feb. 20, 2007) required manufacturers or their designated entities to register their medical devices (except IVDs, which need to be notified through a different process) with the Italian Ministry of Health Database, if the medical devices are to be sold in Italy. The complete listing of all registered devices is organized into a database.

New legislation has since been introduced. Decreto 21 Dicembre 2009 (Decree of Dec. 21, 2009) went into effect on Feb. 6, 2010 and supersedes the directive issued in February 2007. The major change is that Class I medical device registrations with the Italian Ministry of Health (MoH) are no longer required for manufacturers whose European authorized representative is located outside of Italy. Note that registrations are still required for Class I devices of manufacturers whose European authorized representative is located in Italy and, of course, Italian manufacturers of Class I medical devices.

The Italian National Health Service, Servizio Sanitario Nazionale, or SSN, is the healthcare system in Italy. The SSN encompasses multiple health-related agencies, as well as all public health authorities, facilities and hospitals. Therefore, its reach is unending. The catch to the seemingly eased and "lessened" requirements is that only devices that are registered are available to the vast SSN. In fact, the listing of all of the devices available to the SSN is termed the "Repertorio," and it is important to note that all products registered with the Repertorio are subject to a fee of 100 euros. Thus, although Class I devices whose manufacturers have European representation outside of Italy are exempt from registration requirements, if they wish to market their devices within the SSN, they still must register their devices. Unfortunately, however, specifics were not detailed in the decree. In fact, the issue of SSN registration was only briefly mentioned as an option for manufactures of Class I devices to participate in "voluntary registration," but, again, the specifications of which were not explained.

In addition to the section on "voluntary registration," the decree of Dec. 20, 2009, made it a goal to lessen some of the requirements for registration of Class IIa, IIb, and III medical devices, as well as active implantable medical devices. Similar to the vagueness on the registration process for the SSN, the degree to which these requirements have been assuaged for higher-risk class medical devices and implantable medical devices is not clear. In fact, there are several parts of the new decree that are uncharacteristically elusive; so much so, that the Italian Ministry of Health scheduled an internal meeting in mid-February to discuss the issues. Essentially, the decree omits crucial details, and while the official minutes and summary of the internal MoH meeting have yet to been made public, it is anticipated that the ministry will issue guidance to mitigate the confusion that the decree has presented.

What we now understand, and perhaps was not clear in the text of the decree, is that the "voluntary registration" pertains to the need for Class I devices to be registered in order to be marketed within the SSN system.

Furthermore, it is likely that these devices that are "voluntarily" registered also will be subject to the 100 euro Repertorio fee, although this too is not outlined in the decree. So, in practice, unless manufacturers wish to sell their products only to private medical facilities and not to the larger (and more lucrative) SSN, the new decree does little to enact registration reform. This, of course, gave rise to the story of my day of mandatory volunteerism (which, for the record, I completed, rain and all).

Reviewing Requirements

If you are a manufacturer with European authorized representation outside Italy:

• Class I registrations are not required, unless the manufacturer would like to make their Class I devices available within the SSN, in which case device registration (and Repertorio fee) is required.
• Registrations are required for Class IIa, IIb, and III medical devices.
• If your products were introduced prior to May 1, 2007, you must go through the steps of re-registering with the Italian Ministry of Health no later than March 31, 2010.
• If you are a manufacturer with European authorized representation in Italy:
• Registration is required for all medical devices.
• Those devices that were marketed prior to May 1, 2007, must be registered by March 31, 2010.

We hope this has helped to highlight some of the changes to the regulatory landscape in Europe, and more specifically, to explain the "double-edged sword" of the new lightened registration requirements in Italy that for the majority of manufacturers (foreign and domestic), do little to lessen regulatory requirements.

Originally published in March 2010