Placing your product into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law for all 27 member states within the European Union, each member state has its own specific way of implementing the Directive within their country essentially by 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, not only Class I.
All non-EU manufacturers of medical devices are required to use a European (legal) representative to register products with the Italian database.
This representative will communicate with the Italian Ministry of Health on the manufacturer’s behalf. The registration can only be done with granted access to the Italian Database and with the required “smart card” for the actual registration. The legal representative needs to have access to both.
Third party commercial entities, like distributors, prove to not be the most effective way register products for several reasons, a few of which are:
1. By allowing a third party commercial entity to register in a manufacturer’s behalf, the manufacturer relinquishes an essential part of their control over their product in Italy
2. If a manufacturer decides to end the relationship with their commercial distributor at any point, they would be required to take the product completely off the market until they could re-register that product within Italy for a second (third, fourth, etc.) time
3. A manufacturers third party commercial entity will expect exclusivity, limiting the open distribution of all products
1. For the benefit of non-EU manufacturer, the distributor must be cleared from any regulatory affairs
2. The manufacturer should register their products with the Italian database through his appointed European Representative
Local Legislations, such as this one, are growing rapidly in Europe and strengthen the need for a professional European Authorized Representative present at all times. A company looking to succeed needs to stay informed with the wave of changes local legislation can bring.
For more information, contact the source:
Obelis European Authorized Representative Center; Brussels, Belgium.