Placing your medical device on the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 27 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation.
An example of such local implementation of the Directive is now present in Italy which requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14) only in Italy it is applicable for all classes, EXCEPT Class I – which was recently confirmed exempt from the Device registration by the Italian Ministry of Health.
As a non-EU manufacturer of medical devices, you are required to use a legal European representative to register your medical device with the Italian database. Non-Italian (European) manufacturers are also required to complete this registration themselves or appoint a legally-mandated representative to register for them. This representative will communicate with the Italian Ministry of Health on your behalf. The registration can only be done with granted access to the Italian Database, and with the required “smart card” for the actual registration. Your legal representative needs to have access to both.
Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:
1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Italy
2. If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Italy for a second (third, fourth, etc.) time 3. Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device
1. For the benefit of non-EU manufacturers, the distributor SHOULD NOT have part in any regulatory affairs
2. The manufacturer should register their medical devices with the Italian database through his appointed Authorized Representative.
Local Legislations like the example of Italy are growing rapidly in Europe (such as in Portugal) and strengthens the need for a professional European Authorized Representative present at all times