Italian Device Registration

The Italian Ministry of Health (MOH) has implemented mandatory procedures for the Italian Registration of Medical Devices as of May 1st, 2007.

Overview

Placing a Medical Device into the European market is contingent upon 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, not only Class I.

Solution

As a non-EU manufacturer of medical devices, the manufacturer is required to use a European (legal) representative to register their product 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, should not register products for several reasons, a few of which are:

1. By allowing a third party commercial entity to register in the manufacturer’s behalf, he/she relinquishes an essential part of his/her control over his/her product in Italy.

2. If the manufacturer decided to end the relationship with the commercial distributor at any point, they would be required to take their product completely off the market until they could re-register that product within Italy for a second (third, fourth, etc.) time.

3. A third party commercial entity will expect exclusivity, limiting the open distribution of the product.

Conclusion

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/her 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.

See Also

* CE Mark
* Directive (European Union)
* European Union Legal System
* Regulation (European Union)
* List of EU Directives
* Medical Devices Directive

References

* http://www.ministerosalute.it/dispositivi/paginainterna.jsp?id=395&menu=registrazione
* The Italian Ministry of Health
* Active Implantable Medical Devices Directive (90/385/EEC)
* Medical Devices Directive (93/42/EEC)

External links

* http://www.obelis.net/
* http://www.ce-mark.com/FAQ11.html
* http://www.obelis.net/Articles/manufactuerobligation.html
* http://www.obelis.net/Articles/appointear.html
* http://www.obelis.net/Articles/sk_italy.html